Stream.Transcripts/twitch/2116198929 (2024-04-10) - FDA II Study Hall LIVE -- (10 Apr 2024)/2116198929 (2024-04-10) - FDA II Study Hall LIVE -- (10 Apr 2024).vtt

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oh, oh, oh, oh, oh, oh, oh, oh, oh, oh, oh, oh, oh, oh, oh, oh, oh, oh

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I'm afraid that the latest data tells us that we're dealing with essentially a worst-case

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scenario.

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I'm afraid that the latest data tells us that we're dealing with essentially a worst-case

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scenario.

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I think truth is good for kids.

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We're so busy lying we don't even recognize the truth no more in this society.

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We want everybody to feel good, that's not the way life is.

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This episode is sponsored by Moink, that's Mo plus Moink.

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My point is that if we were able to, just like we're trying to get everybody to take

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the vaccine, if we had put that into getting everybody to take Ivermectin and fluvoxamine

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for a month, and if we could accomplish that, then COVID would be wiped out.

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We could do it, and actually any municipality that could regulate its borders could clear

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the disease if you could accomplish that goal, I believe.

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But you can tell if someone's lying, you can sort of feel it in people.

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And I have lied, I'm sure I'll lie again, I don't want to lie, I don't think I'm a liar,

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I try not to be a liar, I don't want to be a liar.

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I think it's like really important not to be a liar.

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It looks a little off to me, is that all right, I think it's okay, I think it's all right.

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I think it's okay, I think it's okay, I think it's okay, I think it's okay, I think it's

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okay, I think it's okay, I think it's okay, I think it's okay, I think it's okay, I think it's

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okay, I think it's okay, I think it's okay, I think it's okay, I think it's okay, I think it's

04:47.440 --> 04:49.440
okay, I think it's okay, I think it's okay, I think it's okay, I think it's okay, I think it's

04:49.440 --> 04:50.440
okay, I think it's okay, I think it's okay, I think it's okay, I think it's okay, I think it's

04:50.440 --> 04:51.440
okay, I think it's okay, I think it's okay, I think it's okay, I think it's okay, I think it's

04:51.440 --> 04:52.440
okay, I think it's okay, I think it's okay, I think it's okay, I think it's okay, I think it's

04:52.440 --> 04:54.440
okay, I think it's okay, I think it's okay, I think it's okay, I think it's okay, I think it's

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okay, I think it's okay, I think it's okay, I think it's okay, I think it's okay, I think it's

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okay, I think it's okay, I think it's okay, I think it's okay, I think it's okay, I think it's

04:57.440 --> 04:58.440
okay, I think it's okay, I think it's okay, I think it's okay, I think it's okay, I think it's

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okay, I think it's okay, I think it's okay, I think it's okay, I think it's okay, I think it's

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okay, I think it's okay, I think it's okay, I think it's okay, I think it's okay, I think it's

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okay, I think it's okay, I think it's okay, I think it's okay, I think it's okay, I think it's

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okay, I think it's okay, I think it's okay, I think it's okay, I think it's okay, I think it's

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okay, I think it's okay, I think it's okay, I think it's okay, I think it's okay, I think

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it's okay, I think it's okay, I think it's okay, I think it's okay, I think it's

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okay, I think it's okay, I think it's okay, I think it's okay, I think it's okay, I think

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it's okay, I think it's okay, I think it's okay, I think it's okay, I think it's

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okay, I think it's okay, I think it's okay, I think it's okay, I think it's

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okay, I think it's okay, I think it's okay, I think it's okay, I think it's

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okay, I think it's okay, I think it's okay, maybe it's okay, I think it's okay, I'm

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okay, I think it's okay, I think it's okay, I think it's okay, I think it's okay, I healing

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I've got to do it. If you've been here for a while, you're here at the top of the wave. If not, you might be a skilled TV watcher.

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A need of rescuing the way out is to stay focused on the biology. You don't take your bait on TV and love your neighbor.

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The way this stream has found you is because people are consistently spreading the word each week, each day.

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And that's what keeps this happening. People like Suitspider working hard behind the scenes to get stuff out to make it easier for people to find it.

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It all helps. You can find me at giggleandbiological.com in a lot of different places. I don't need to run through all of that.

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I do have to say, though, that this list is growing. It's just not yet sufficient to support a family of five in Pittsburgh who's renting their house.

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It is growing. And I do have, occasionally, I am blessed with other ways of making scratch. And so I have been doing that.

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I have a lot of reading to do. And I do think that it would be great. Suitspider seems to be hip to something. Maybe he's listening to my messaging and other platforms.

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It would be great if you would open up a window. If you have sufficient bandwidth.

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If you have sufficient bandwidth, it would be great if you'd open up the stream.giggleome.bio in the background. You can put it on mute.

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We just want to try and see how many people that platform can take before it cracks. We have ways of watching this stuff in the background.

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We're going to try and figure out whether or not we have an overloaded server very easily or whether we've got a lot of excess capacity because if Twitch goes away, if these other platforms have a problem, we still have our own website and our own archive.

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We're building it now. And so helping us test that would be great. On the other hand, if you just got enough to watch Twitch, then just do that. I understand that very well.

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And thank you very much for joining me.

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This is a presentation of the Intellect Independent Bright Web. It is kind of the polar opposite of the intellectual dark web.

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And I'm very, very pleased that more people are catching on to that idea.

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The illusion is sustained only through your active participation and even the best of us probably still have a long way to go before we're going to be fully, fully disengaged from the illusion that is our recent history, our recent academic science in some fields, many fields.

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We're going to have to catch up to this illusion pretty quick. And United Noncompliance is the way out going forward.

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That's our primary recommendation here at Giga Home Biological.

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I sounded like kind of a know-it-all though during the eclipse and I was a little embarrassed of that, but I thought I had to release the video anyway because it was so pretty.

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Because my daughter was so cute with the little worm in the sky and stopped talking.

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Giga Home Biological is the safest way to get biology in your head. That's what we're trying to do here on the 10th of April, 2024.

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The last time we left off, we were actually watching the first part of an FDA interview, FDA Seminar rather, that was given on February 3rd, 2020.

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Well before the lockdowns were declared, just every speaker insists that this seminar was taking place just luckily enough.

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They've been scheduling it for months and months, but just happens to be that there's a new pandemic and we're just talking about EUAs.

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And so this, I felt like this presentation was really important to keep revisiting and in the sense of watching the second half of it because when we left off, we had just gotten a lecture from someone from Inkutel, followed by someone who told us all about how testing went with regard to Ebola

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and how she evaluated the effectiveness of different tests for Ebola. And then upcoming where the next three people were going to be FDA people basically explaining how to get your EUA to full market status.

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At least that was the title of the seminar. And so that's what I want to do today.

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Remember that our hypothesis is pretty basic. You know, we think that the who declared a dangerous novel virus was about to cause a pandemic and then a coordinated effort and included the rollout of nonspecific PCR tests on a background that they had already previously

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characterized and very careful control of sequencing by a central location, basically controlled by DITRA so that the, the, the phylogeny of the first say six months, nine months, whatever, how long we could find out in retrospect, DITRA was involved in curating this, this, this phylogeny.

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They created the illusion of spread of different variants change the variants whenever they wanted to. This was all well within the purview of this control over the sequencing, which is now purported to be over 15 million sequences worldwide. But of course, if there was already a background there,

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careful control of the original sequencing and its progression through a phylogenetic tree and that at some point, an open call for everybody to buy the primers and start sequencing stuff would be a very easy way for, for a background signal to be converted into irrefutable evidence of spread. And I think that's basically what they did.

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And they use that irrefutable quote unquote evidence of spread to convert an all part of an all cause mortality, which would have essentially been caused.

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That would have been called called pneumonia and influenza PNI. They took that, that basic umbrella of, of all cause mortality and they converted it to this new novel cause by using this test for a background that they knew was already there.

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And also confounding it right because they gave financial incentives for people to follow these protocols and even financial incentives and a wide berth with with within which to declare COVID because there weren't tests in America.

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For a very long time. And so it was hard to characterize exactly what was going on because, of course, without molecular tools, who knows, but since we thought it was coming and it came, I guess it must have arrived and then spread.

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But there's no evidence of this epidemiological spread. And instead, there's just a lot of insistence that that happened at a lot of spectacular commitment to that narrative.

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The, the sort of nails in the coffin that I think are most important are our, are incremental understanding over the last really over a year now is our understanding of how pivotal the development of recombinant DNA technology was to RNA virology because it permitted

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the creation of and the production of infectious clones as a catalog starting point for any pathogenic study. And that, that really, at first, of course, when Vincent Rancin yellow and, and David Baltimore did it with the, the polio virus, it was kind of a proof of principle type thing.

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Eventually, of course, this becomes a way of otherwise getting a hold of RNA viruses that don't grow in a cell culture that can only be that can only be amplified through PCR of particular samples. And so, although the shadows of, of an RNA signal are present in a lot of these samples, a lot of these samples simply

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couldn't produce the full replication competent virus that was assumed to be there. But instead, in order to bridge this gap, coronaviruses were basically given a, a sort of, let's say, a toolbox within which they could be created. And that's really

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what Ralph Barrack should be care what should be, I guess, lauded with finding is that if we took this enzyme and this enzyme and this enzyme and this enzyme and then added this novel spike protein, essentially, we would have a replication competent RNA species that would work inside of one of our cell cultures and produce the signals that we have used as a proxy for an indication of a replicating virus.

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And so without a high fidelity understanding of how the infectious cycle works, Ralph Barrack was able to circumvent that by identifying a few, let's say, absolute minimum requirements for a replication competent RNA coronavirus and then for the next several years when they found a novel spike protein

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by using PCR on all of these random samples, they would assume that that spike protein was indicative of the existence of an entire RNA species defined by the coronavirus stereotype of a 30,000 base pair genome that encodes, let's say, 30 of these proteins. And so, every time they identify a protein in theory, they could say, well, we didn't find that one before, but if we took this enzyme, we would have to do that.

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And now we found another coronavirus protein. This one's pretty handy. And so actually, what you can see the history of coronavirus as is a slow mining of this RNA signal across time and a an assembly of what is called a consensus genome of an RNA coronavirus.

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But you could also just see it as a consensus assembly of the genes that seem to be minimally required in order for an RNA to be replication competent in the context of a hexazole.

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And so, in the sort of fantastic conspiracy theory, imagination of mine, one of the first ideas that came to my mind a long time ago was, have we been misled the whole time?

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Have they always been trying to piece together this, this exosome signal and knowing all along that exosomes are, in fact, limited replication competent RNAs that are used to signal between

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either tissues or and or between conspecifics.

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And so imagine a scenario where the immune systems of mammals can communicate with other of their kind using exosomes that are limited temporal duration replication competent RNAs that can amplify themselves as they, they move through a conspecific population

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for a limited time as an immune signal.

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And if this was supposed to happen between social groups if this was supposed to happen between family groups in order to insulate they each other, there are lots of biological concepts that could in theory come into play.

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If you acknowledge the fact that we know exosomal communication exists, we know that whole departments existed before the pandemic that have been often on absorbed by different cancer departments or infectious disease departments.

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But always there is this agreement in across NIH and in Dutch science and German science that exosomes are important.

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Cancer biologists know that tumors release exosomes which are detectable discernible from the background.

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And so now, if we have been experimenting with how do we harness this technology for genetic manipulation and for medical purposes is dual use things.

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If we have been looking at this background signal as a potential background signal that also belies potential biotechnology, then what better way to disguise this, this investigation by saying that wow we found novel pathogens out in the wild and bats have a lot of them.

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Why do bats have so many coronavirus is it because they're so weak because they're so strong, or because their immune system sends out more signals than the average than the average mammal because they live in such large packed, you know, there's lots of biological

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plausibility here with the idea that bats have so many, let's say tasty virology treats in them for a different reason than them being just really dirty, which is again right this is the idea.

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But what if they have an especially actively signaling immune system that unique among mammals is one of these places where we can get a good handle or a better handle on what what immune signals are present at this size scale.

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Now, am I saying this is right? No.

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What I'm saying is is that there's a lot of biological plausibility in the idea that there is a broad background signal of RNA and DNA that people like Nathan wolf been going all around the world talking about how cool it is that these signals exist.

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Where's his book.

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Nathan wolf the coming viral storm. Right. The pan the the the dawn of a new pandemic age when did this book come out.

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I mean the grift is long ladies and gentlemen this has been going on a long time being set up for a long time these people have been meeting and talking about how this mythology will go.

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Sharing their ideas on that mythology and books.

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Carefully crafted books that that seem innocuous but in reality it's like oh is that what you think Nathan that's a pretty good idea I like that part of your book.

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We should use that in the next tabletop exercise.

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A lot of what Nathan wolf's original sales pitch was was if you see it right is just revealing that this background is almost infinite.

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And he used to call it the dark matter of life that maybe new life forms when he merged from there's so much data there.

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All he needs to do is collect it and get his algorithms into it it's a it's a very when you hear him talk, you can hear such a charlatan especially if you know where we are now 15 years later.

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He was talking about using AI and artificial intelligence to sort through this random DNA signals and RNA signals in the background to find new life forms new viruses that was this whole thing that's what this whole book is about.

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And so you cannot underestimate how how uncharacterizable.

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The background RNA and DNA noise is in our living world.

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And anywhere where the ecosystem is really working still like in a rainforest or or or or deep in a national park in the soil.

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You're going to see a a background that is simply uncharacterizable there's no way for us to measure all the all the RNA and DNA signals that are in the soil of Yellowstone National Park in a in a small soil sample with all the microbes that live in there.

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It's not possible. And so when we use a PCR test that says oh yeah see we have fluorescence over here. And there's no sequencing involved at all there's no follow up there's no there's no experiments that follow that's where that's where we get trapped.

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But that high fidelity we are sure that these signals are real that belies their their illusion. And it's the agreement across the board.

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Tony Fauci and Robert Malone do not disagree about the database of sequences that represents the pandemic. Neither does Kevin McCurnan.

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Neither does Buckholtz neither does Robert F Kennedy Jr.

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None of them really question the idea that PCR was overcycled is an idea that somewhere in there is a sweet spot where it is actually detecting something you see.

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And get together and write a paper that objects to the PCR primer dimers that form because drawston picked the wrong PCR primers you're actually arguing for a better PCR test and arguing under the pretense that PCR is a great idea.

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And so most of us wittingly or unwittingly were walked right into accepting that there was a novel virus based on how we were coerced tricked enticed into approaching this mystery.

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And very, very few of us, even the best of us that were already well aware that 911 was some elaborate theater.

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We couldn't immediately jump to the full conclusion that the whole thing, the whole thing from the very beginning is a theater.

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There probably isn't even a real deal.

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And that because they have planned over decades because they have rehearsed over decades because a lot of these people are career climbers of the hierarchy.

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And they know what to do now when the alarm goes off and the alarm definitely went off around the world there was an agreement.

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The alarm was definitely going off and so a, a, a sort of national security incident occurred.

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There are proven molecular biological techniques that have existed for more than a decade which would enable a very high signal to noise ratio to be created.

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So that all of these therapeutics sorry all of these diagnostics and all of these attempts to characterize the spread of this novel pathogen on a characterized background would be absolutely indistinguishable.

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From what they are calling a pandemic.

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It would look exactly like it.

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And the one thing that is so hard to imagine is that if there was a background signal that we were not testing for all true.

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And they had previously characterized it before they told us there was spread.

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Then the orchestration of variants and sub variants coordinated by a careful release of data by DITRA.

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Would have allowed a assembly of a tree that once they said okay now everybody send in sequences, they would have by definition had to have fit on the end of that tree and it would have been fine there's no it doesn't matter anymore.

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Because the, the story that the assumption and the mystery solving context has already been laid out by the end of 2020.

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And all people have to do is just point back to that and say well yeah but there's that.

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And so it had there had to be covered.

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That's all they have.

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And that's really what's very spectacular because in the end this total surrender of individual sovereignty there can't be any evidence.

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That's the whole magic of the way that they did it if this is a spectacular commitment to a mythology and the real laying it down.

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And everybody that's involved thinks that they are about to be accepted into a group by by by performing this service.

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Then then then you're never going to see anybody break character.

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No one's ever going to jump off because they think that they are in fact working for the weaponized piles of money that currently run the globe.

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Millions and trillions of dollars and maybe that's even an understatement but I think trillions and trillions of dollars is what we're talking about here and so we are being made to look over here at the shiny objects called billionaires

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but those are little little play pieces.

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They have some power they have some freedom that that normal people do not have.

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And they also are keenly aware of who's above them I'm sure of it.

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They've been reminded because the people above them permitted them to become billionaires that's what you need to understand that a lot of people don't is the Jeff Bezos was permitted to become a billionaire Bill Gates was permitted.

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Elon Musk was permitted these people are not are not there because of blood sweat and tears in their own calluses on their hands don't be silly.

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These people have been given opportunity in a wide variety of ways from military technology that they're allowed to roll out as their own to opportunities that would otherwise not be there for for government funding and programs to take over under the pretense of being your own company.

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These are illusions that are created in order to govern our children by them.

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That's why these same people are so prominent on social media.

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The people that truly run the world are not are not on social media giving TED talks or sitting in uncomfortable chairs for 45 minutes on a stage.

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And once you realize that and you see these people for the auditioning puppets that they are, then it's very easy to to to move forward and to really start to see that people like Scott Shara are the people that we need to be listening to.

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We need to check out of the dialectic.

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We need to stop choosing between their choice or their choice.

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Heads they win tails you lose that's the kind of choices that we are being given and fighting about who's right with regard to.

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And if we don't pull our heads out our children will not be able to extricate themselves from this because they need our help they need us to to come to our senses and and we need to apologize for not having come to our senses sooner.

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We're not having run for school board last year or for City Council last year. There's a lot of things that need to happen and some of you people out there in the audience.

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It's time for you to take action and real action.

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And I really mean that when I say city council or school board.

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Maybe church service something like that.

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It's time.

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So I say this a lot but I really think more and more that they are really trying to make you fear your neighbor fear the people around and I there are probably people.

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First and foremost, it is important for me to say that I think one of the reasons why sometimes decide not to stream is because I'm not able to.

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I'm not able to clear the the foulness of what I've gathered in the day.

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And some of that's my fault.

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And some of that's just the world that we live in some of that is the, the, the daily grind.

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And I won't come online if I, if I have, if I'm not in the right place. And so I'm human just like you. And, and we definitely have this issue of needing to pay rent. And so, as I said before, I took the last few days off, not only for an eclipse on Monday, but

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because trying this out.

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I love the old game shows. I'm sorry. I had to use that.

32:06.440 --> 32:11.440
So today we're going to go back to this, you a market video.

32:11.440 --> 32:14.440
And, and see what we can make of it.

32:14.440 --> 32:18.440
James Corbett has done a ton of great work.

32:19.440 --> 32:28.440
I think it's, it's strange, right? Because essentially what we can assume, and I'm not saying this about any particular person.

32:28.440 --> 32:39.440
But unless you're really scraping by and having no help and no assistance and only experiencing.

32:39.440 --> 32:45.440
What I would call throttling where no matter what you do, your growth is extremely linear.

32:45.440 --> 32:49.440
And there are no bumps in visibility.

32:49.440 --> 32:55.440
And only bumps in invisibility bumps in flower follower loss.

32:55.440 --> 33:02.440
Then, then the only thing that I can assume is that we just have to keep grinding.

33:03.440 --> 33:21.440
And it's hard sometimes. I will really admit, it's hard because you see Brett Weinstein and look at his, at his statistics and there are weeks and weeks in a row where he's gaining 50,000 followers a day at times and it's, it's hard to understand at this stage.

33:21.440 --> 33:24.440
And I think it's, it's hard to understand.

33:24.440 --> 33:26.440
And I think it's hard to understand.

33:26.440 --> 33:28.440
And I think it's hard to understand.

33:28.440 --> 33:30.440
And I think it's hard to understand.

33:30.440 --> 33:32.440
And I think it's hard to understand.

33:32.440 --> 33:34.440
And I think it's hard to understand.

33:34.440 --> 33:36.440
And I think it's hard to understand.

33:36.440 --> 33:38.440
And I think it's hard to understand.

33:38.440 --> 33:40.440
And I think it's hard to understand.

33:40.440 --> 33:42.440
And I think it's hard to understand.

33:42.440 --> 33:44.440
And I think it's hard to understand.

33:44.440 --> 33:46.440
And I think it's hard to understand.

33:47.440 --> 33:52.440
It's frustrating, you know, it's frustrating, but it's the way that, that this whole.

33:52.440 --> 33:54.440
Thing is going to go forward.

33:54.440 --> 34:00.440
It's not going to get any easier. And so for me to keep coming on here and.

34:00.440 --> 34:01.440
And.

34:01.440 --> 34:14.440
I just, I, I only have a few, few data points to share and unfortunately, Brett, Brett Weinstein is definitely one of those data points and it's always going to be something that we mentioned.

34:14.440 --> 34:20.440
It'll probably always be something that, that appears every once in a while in the introduction.

34:20.440 --> 34:25.440
Because it's one of those, those things that, that cannot be forgotten.

34:25.440 --> 34:28.440
One of those pieces to the puzzle that cannot be forgotten.

34:28.440 --> 34:35.440
And it's a link to the past through his father to the, to the present through his brother.

34:36.440 --> 34:55.440
And to the rest of this intellectual dark web that the independent bright web is really my own sort of tongue in cheek response to, to what I'm sure was a an effort orchestrated by a weaponized pile of money and maybe more than one.

34:56.440 --> 35:05.440
So speaking of, of seminars, this is the seminar that I want to watch today.

35:05.440 --> 35:09.440
And I don't know why I'm taking so long to warm this up.

35:09.440 --> 35:12.440
Let me see.

35:12.440 --> 35:18.440
Where did you go? Here you are. So this was the last lady we watched.

35:18.440 --> 35:23.440
And then I think there is a brief.

35:23.440 --> 35:28.440
Oops, I think there is a brief. Where is there it is.

35:28.440 --> 35:32.440
I think there is a brief, please work.

35:32.440 --> 35:36.440
And a framework for actual development and evaluation.

35:36.440 --> 35:41.440
I think there is a break where they see she's doing the acknowledgments.

35:41.440 --> 35:46.440
Now there's a break where they have some trouble with the slides, but I want to hear the introduction of the people that are coming.

35:46.440 --> 35:52.440
And then, and then maybe I have to fast forward it or something like that. Here we go.

35:52.440 --> 35:54.440
Very thought perfect thing.

35:54.440 --> 36:02.440
Okay, we're going to shift gears just a little bit and hear from the FDA on the perspective on the situations.

36:02.440 --> 36:07.440
So join me in welcoming the following representatives from FDA and FDA representatives.

36:07.440 --> 36:12.440
If you would come up and go ahead and sit down in your seats up here.

36:12.440 --> 36:14.440
You can see their name tags there.

36:14.440 --> 36:19.440
I have real Admiral Denise Hinton FDA chief scientist.

36:19.440 --> 36:28.440
Tim stencil MD PhD director of OHT seven and office of in vitro diagnostics and radiological health for CDRH.

36:29.440 --> 36:34.440
They sharp PhD director division of my microbiology devices for H two seven.

36:34.440 --> 36:41.440
Oh, I are Michael waters PhD shield team leads CDRH RWE tactical team.

36:41.440 --> 36:44.440
Oh, I are representative.

36:44.440 --> 36:47.440
I understand some of you may have slides.

36:47.440 --> 36:52.440
So Mike, if you want to come help me at least pull up the slides that would be great.

36:53.440 --> 36:58.440
Wow, she can't pull up the slides. Remember, she was also excuses. I'm only one handed and it's my left.

36:58.440 --> 37:01.440
Oh, oh, wow. Okay. That's a little bit.

37:12.440 --> 37:13.440
Okay.

37:23.440 --> 37:30.440
I think the rear Admiral just said that she doesn't have any slides, which is interesting.

37:30.440 --> 37:41.440
I'm really curious as to what we're going to say here. So I'm just going to wait for a second because I don't know if they're going to put something up here, or if I just need to make this big, maybe I'll just make this big.

37:41.440 --> 37:44.440
I don't think she has any slides.

37:53.440 --> 37:58.440
See, she does. Oh, no.

37:58.440 --> 38:04.440
Oh, that was that. Oh, come on now.

38:04.440 --> 38:06.440
Oh, boy.

38:06.440 --> 38:15.440
I don't know if you guys noticed or not, but Matt Briggs just did a course on Twitter. He posted it on Twitter.

38:16.440 --> 38:41.440
It's a, it's an impromptu taught course. And so it's a little of a bumpy start in that sense, but it's a good first introduction to where we want to go with probability and uncertainty and how those two ideas have been contorted in the process of our science becoming

38:41.440 --> 38:45.440
prepared to prepare him.

38:45.440 --> 39:00.440
But I do think that we're going to be able to make something really nice of it. And I think I might do that later tonight. So one of my strategies going forward is to just try and put out more content and more often.

39:01.440 --> 39:13.440
And so it'll be less slides and more of this kind of stuff of watching things and taking notes and discussing it because the slides are often the themes of the slides are going to get pretty repetitive.

39:13.440 --> 39:19.440
We do have to also go back to pre-arms if these guys would get going.

39:20.440 --> 39:21.440
Thank you.

39:24.440 --> 39:29.440
Good morning, everyone. Okay, I don't have a slide. So we don't have a slide.

39:29.440 --> 39:32.440
Sure.

39:32.440 --> 39:35.440
There we go.

39:39.440 --> 39:44.440
Okay, so I think like in Cutell lady, I think she's probably just going to read a warning to us, but we'll see.

39:44.440 --> 39:48.440
Thank you again. Good morning, everyone. Pleasure to be here with you this morning.

39:48.440 --> 39:52.440
Before I go into formal remarks, I just want to thank you all for being here.

39:52.440 --> 40:02.440
Last Thursday, as you know, the World Health Organization declared the novel coronavirus and outbreak of public health emergency of international concern.

40:02.440 --> 40:10.440
And the global effort now underway to halt its spread truly underscores the importance of the work we're doing here today.

40:11.440 --> 40:18.440
Collaboration and coordination are always desirable, but in this case, they are absolutely mandatory.

40:18.440 --> 40:35.440
As you know, FDA collaborates with interagency partners, product developers, international partners, and global regulators to expedite the development and availability of medical products needed to mitigate, diagnose, treat, and prevent outbreaks.

40:36.440 --> 40:50.440
To support efficient medical product development for novel coronavirus medical countermeasures, FDA has established a webpage providing key information for the public, including product developers on FDA efforts in response to the outbreak.

40:50.440 --> 41:00.440
Diagnostic products regulated by FDA play a key role in response efforts since identification of disease enables intervention at the earliest stages.

41:01.440 --> 41:08.440
Our efforts focus largely on facilitating the development and availability of safe and effective medical countermeasures.

41:08.440 --> 41:20.440
Those being products like diagnostic tests used to detect protect against and respond to chemical, biological, radiological, and nuclear threats, including emerging infectious diseases.

41:21.440 --> 41:31.440
Since 2012, FDA has approved license or cleared more than 160 medical countermeasures for a diverse array of threats with significant advances in diagnostic space.

41:31.440 --> 41:45.440
For example, in 2019, FDA approved commercial marketing of three diagnostic tests to detect the virus and bodies in a rapid diagnostic test to detect the polar virus, and agents in human blood.

41:46.440 --> 41:56.440
At the outset of an outbreak, especially of unknown source, like the current novel coronavirus in Montana, there typically are no tests legally marketed for clinical use.

41:56.440 --> 42:12.440
FDA experts work closely with the U.S. government and international partners to speed the processes necessary to make tests available for emergency use under FDA's emergency use authorization or EUA authority.

42:12.440 --> 42:23.440
For example, within days of receiving the genetic code for the 2019 novel coronavirus, FDA drafted EUA reviewed templates for CDC and other developers.

42:23.440 --> 42:31.440
As was done for Zika, FDA is working to develop reference materials for developers to use to validate their diagnostic tests.

42:32.440 --> 42:36.440
Since 2009, FDA has issued more than...

42:36.440 --> 42:53.440
So what she's admitting there is that without a virus sample or without a patient sample or a standard of some kind, there's no real way for anybody to evaluate whether or not their diagnostic test works.

42:53.440 --> 42:58.440
Are you detecting the protein you say you are? Are you detecting the sequence that you say you are?

42:59.440 --> 43:24.440
Now remember, of course, the generation of sequences that match the viral sequence or short sequences that can be used to show that look our primers will amplify this sequence is very different than showing that in a sample known to be positive in a sample known to be negative, you get the right result three times.

43:24.440 --> 43:35.440
And she is admitting that in February 3rd of 2020, at least, they were still working on creating standards for these diagnostics to be evaluated.

43:35.440 --> 43:39.440
So EUAs are going to be given out and keep this in mind, please.

43:39.440 --> 43:47.440
EUAs are going to be given out where no diagnostic evaluation, real effectiveness, could be even evaluated.

43:48.440 --> 43:55.440
There weren't enough people in February 3rd of 2020 to even collect samples.

43:55.440 --> 44:02.440
When was the Homish County man? You see?

44:02.440 --> 44:09.440
And now the trick will be is that if you had a virus that didn't grow well enough in a culture, then there would be no...

44:09.440 --> 44:21.440
And even if it does grow well in a culture, it doesn't know virus found in the wild taken from a human has been able to produce an infinite quantity of virus afterward.

44:21.440 --> 44:32.440
Yes, you can make a little more RNA that allows you to sequence often the whole virus, but that's because, as we understand, during the infectious cycle, a lot of subgenomic RNAs are made.

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And when you amplify all the RNA in a sample like that, you don't get to differentiate between subgenomic RNAs and RNAs that cover more than one because there are subgenomic RNAs that cover more than one gene.

44:49.440 --> 44:57.440
They're all the intermediate lengths. They say it. They show it. They've known it for decades already. All the old virology books show the same thing.

44:57.440 --> 45:10.440
The subgenomic RNAs, when assembled like Nathan Wolf would assemble them, or when assembling using metagenomic sequencing, you don't get things that are there. You get a consensus about what's there.

45:10.440 --> 45:19.440
And the alignment assumes that what's there represents something that is that long, that is containing of all of those things.

45:19.440 --> 45:42.440
But it's an assumption, because we are essentially asking the wrong question. We should be backed up one step and still saying, have the virologists really justified the fidelity of these RNA signals they call coronaviruses to justify the idea that they could possibly pandemic in the first place,

45:42.440 --> 46:03.440
even if these RNAs could be made in quantity. And even if those quantities of RNA would be self-replicating for a little while and spread through people for, even if all of those things were true, that's very different than those same RNAs being in a bad cave and doing the same thing.

46:04.440 --> 46:24.440
And that's because in order to make a standard coronavirus, they would need to use recombinant DNA and make sufficient quantities of it and then convert it to an RNA or not, in order to produce the sample that would be used to test PCR tests.

46:24.440 --> 46:37.440
Or they would have to convert it to a protein like actually make spike protein and then send that around for people to use as an assay control for spike protein in a lateral flow test.

46:37.440 --> 46:43.440
They're working on it. They're working on it.

46:43.440 --> 46:55.440
So where'd all the lateral flow tests come from then? Where'd all the antigen tests come from? What do they use as controls? This was all needing to be done in a couple months. Do you see where we are?

46:55.440 --> 47:03.440
This is February 2020, February 3.

47:03.440 --> 47:16.440
McCarron and I haven't even done our first stream. Fauci hasn't even gone on and said anything about lockdowns yet. This is still a month and a half before that.

47:16.440 --> 47:27.440
And she's already talking about a dangerous pandemic and the EUAs that will follow and how exciting it is that we already know so much from Zika and Ebola and everything else.

47:27.440 --> 47:40.440
Dove tailing right behind the one that just told us all about testing any bull and dove tailing right from the lady who read a statement from in CUTEL.

47:40.440 --> 47:45.440
What an interesting seminar to be a part of.

47:45.440 --> 47:57.440
CEUAs to name of the emergency use of diagnostic tests for the threat agents such as H1N1 and H7N9 influenza viruses, MERS, coronavirus, Ebola and Zika.

47:57.440 --> 48:06.440
We are committed to working with stakeholders so that more diagnostic tests move from EOA to for marketing status.

48:06.440 --> 48:13.440
But more than just approving or not approving products is our mission to protect and promote the public health.

48:13.440 --> 48:24.440
At the center of this work is our ability to ensure that the products that are developed are safe and effective by making regulatory decisions based on sound science and high quality data.

48:24.440 --> 48:31.440
We are constantly looking for improved ways to collect and analyze the data that can help us make regulatory decisions.

48:31.440 --> 48:47.440
Questions FDA continually asked are how can we perform our mission as effectively and as sufficiently as possible and how can we accelerate the process of effectively and efficiently generating and applying the necessary data to make regulatory decisions.

48:47.440 --> 48:54.440
The answer lies in FDA's commitment to providing clear regulatory guideposts.

48:54.440 --> 49:07.440
Finding solutions requires bringing key people from diverse sectors and their data together at the same table and taking the input of one another seriously as we're doing here today.

49:07.440 --> 49:18.440
Without the right tools standards and approaches to assess the performance of medical countermeasures, it's difficult to generate the data necessary to support regulatory decision making.

49:18.440 --> 49:36.440
Therefore, FDA has established a broad and diverse robust portfolio of cutting edge research under the MCMI regulatory science program to assist developing the necessary tools standards and approaches to help translate science and technology into innovative, safe,

49:36.440 --> 49:40.440
and effective medical countermeasures.

49:40.440 --> 49:44.440
FDA supports both extramural and intramural research.

49:44.440 --> 49:57.440
Example projects include supporting a project to conduct the largest Ebola virus and host gene expression study to date to assess how the Ebola virus evolves and spreads within the body.

49:57.440 --> 50:06.440
And developing methods for obtaining information on the performance of medical countermeasure products used during public health emergencies.

50:06.440 --> 50:23.440
Specifically, with respect to diagnostics, some of our noteworthy projects include supporting a project to pilot standardized processes for describing and transmitting lab data to accurately track the emergence prevalence and spread of infectious diseases and into my work,

50:23.440 --> 50:26.440
and antimicrobial resistance in real time.

50:26.440 --> 50:30.440
You will hear more about this project later today from Michael Waters.

50:30.440 --> 50:40.440
With respect to supporting development of diagnostic tests for antimicrobial resistant threats, FDA and CDC have collaborated to develop the AR isolate bank.

50:40.440 --> 50:46.440
A centralized repository of microbial pathogens with well characterized resistance profiles.

50:46.440 --> 50:58.440
The AR isolate bank is a valuable resource for biotech and diagnostics groups in researching diet designing and validating and evaluating next generation clinical tests.

50:58.440 --> 51:11.440
Collaborating to establish and support ongoing populations of a publicly available genomic sequence reference database for use by developers seeking to validate candidate multiplex IVD tests.

51:11.440 --> 51:15.440
We are also working to modernize FDA.

51:15.440 --> 51:19.440
We recently announced a technology modernization action.

51:19.440 --> 51:34.440
So that word salad was saying that they have some kind of AR isolate bank, which I think it was she was also referring to possibly sequences having to do with resistant bacteria that people might want to develop diagnostics for.

51:34.440 --> 51:47.440
And then this data bank would be useful to people that wanted to build a multiplex diagnostic.

51:47.440 --> 52:03.440
So multiplex diagnostics, for example, are like this, what was it, is a biofire where they do 17 or so amplicons for different 7 or 17 different variants of RNA viruses.

52:03.440 --> 52:08.440
This kind of test.

52:08.440 --> 52:27.440
It can't be underestimated how nefarious potentially this could be. And also how absolutely misleading it is from the perspective of of naive and under trained medical staff, but also just from the general public that we have gone from in 2020.

52:27.440 --> 52:43.440
Really not trying to track any of these RNA species to now in 2024, purporting to be able to have diagnostics which are useful in tracking 10s if not 20 or 30 potential pathogens in the background amongst these people.

52:44.440 --> 52:50.440
And of course, this is going to be a whole new revenue stream if something like this were to become standard of care.

52:50.440 --> 53:05.440
This could be devastating from the perspective of us having a good grasp of what's going on versus being sort of artificially diagnosed as having things because of what I would call molecular biological noise.

53:06.440 --> 53:27.440
Not that these techniques don't work, but we are assuming that all of these people that are engaged in the production of these diagnostics despite, I guess, having day jobs before it was it was a pandemic that all of these people have to have had some foreknowledge that this was this was going to be a business opportunity.

53:27.440 --> 53:38.440
This was going to be the way it was going to be done. And more importantly, you'd already have to be kind of in on the idea that this is this is an ongoing thing.

53:38.440 --> 53:48.440
Nobody who has a normal life would think that somehow I'm going to get into pandemic testing.

53:48.440 --> 54:00.440
Multiplex diagnosis of respiratory RNA pathogens is a very, very specialized field that for one reason or another has become a billion dollar industry.

54:00.440 --> 54:13.440
And it seems to have started right here. This woman has said diagnostics diagnostics diagnostics in the context of Zika diagnostics and Ebola diagnostics and circle back to Ebola diagnostics.

54:13.440 --> 54:23.440
And then went back around to say that we don't have any standards for the current set of diagnostics that we're about to give you a sport.

54:23.440 --> 54:37.440
Planner what we call T map to help provide a technological foundation for developing FDA's ongoing strategy for the stewardship integrity, security quality control analysis and real time use of data.

54:37.440 --> 54:49.440
Watch for more information as this effort moves forward. If you follow a doctor Amy Abernathy's tweets, you will get the latest and current updates in conclusion.

54:50.440 --> 55:03.440
At FDA, we have made it a priority to proactively work with our private sector and government partners to help facilitate the translation of discoveries and science and technology to safe and effective medical countermeasures.

55:03.440 --> 55:14.440
FDA takes seriously our responsibility to help drive and foster innovation as part of advancing public health and strengthening our national security.

55:14.440 --> 55:23.440
And we remain deeply committed to protecting promoting the public health, both domestically and abroad in response to the public health threats.

55:23.440 --> 55:38.440
There are tremendous opportunities to continue to further the development of groundbreaking and innovative medical countermeasures and to apply 21st century tools and technologies to optimize preparedness and response capabilities.

55:38.440 --> 55:54.440
We are looking forward to hearing your ideas today and working with all of you. Thank you once again for participating in this workshop today. And I want to say thank you again to Dr. Lou Broyo, who was at the head of all of the MC my work and leading this effort.

55:54.440 --> 56:01.440
So thank you for continuing to be engaged and involved in we lodge you and commend you for your efforts. Thank you all.

56:01.440 --> 56:14.440
So she said at the end they're strengthening our national security I don't think you can underestimate how important it is every time they mention that because if it's under the pretense of national security then lying is okay.

56:14.440 --> 56:31.440
And it's really important to know that that if it was if it was any other thing this would not be acceptable but actually under the pretenses of national security even good people can tell lies and agree to tell lies together at seminars or to not talk about certain

56:31.440 --> 56:35.440
imperatives that they know are about to come into play.

56:35.440 --> 56:43.440
That's what I think you see here is this is signaling to one another well I'm the dam is about to break the bell has been run.

56:43.440 --> 56:52.440
And you know that strengthening our national security is a priority. My name is Tim Stenzel and I direct the office of any future diagnostics and biological health here at the FDA.

56:52.440 --> 57:05.440
That's in OPEC and also CBRH. Thank you for that presentation highlighting what we're doing here at the FDA.

57:05.440 --> 57:19.440
So before going into my prepared slides today, you know, this is an amazing timely workshop and we're sort of appreciative of everybody being here both in person and online today.

57:19.440 --> 57:24.440
So as others have already said we began planning for this workshop long ago.

57:24.440 --> 57:29.440
And we have the idea for when we were assessing current needs in the U.A. space.

57:29.440 --> 57:46.440
And I'll highlight later in my in my slides today the urgent need to see more and more of products that have been given the authorization to come in and back through full authorization is we looked at this opportunity.

57:46.440 --> 57:58.440
And to assess what was the what were the barriers to getting to that point. And we'll be discussing those. And some of those have already been very eloquently discussed already today.

57:58.440 --> 58:12.440
So we're very grateful to all of our partners, both within the FDA where we receive a lot of support in the department, both in the United States and around the world.

58:12.440 --> 58:23.440
And I do want to highlight the CDC on our other partners within HHS HHS who has done such a wonderful job so far in this outbreak and previous topics.

58:23.440 --> 58:30.440
So, with that, I'll go ahead.

58:30.440 --> 58:42.440
So my office, our office was recently involved in reorganization and now we're part of OPEC, one of the OHT is where the OHT seven.

58:42.440 --> 58:52.440
And I wanted to highlight our CDRH mission, which really is to provide high quality, safe and effective medical devices of public health importance.

58:52.440 --> 59:07.440
It's our goal to be first in the world wherever possible to authorize new tests and also first in the world when we recognize post market surveillance signals.

59:07.440 --> 59:21.440
First is a way of a brief overview of medical device regulations and where you a sit in, and how you go from an EU way to a fully authorized device wanted to go through a few of these steps now.

59:21.440 --> 59:36.440
So this list, the definition of a medical device section to a one H states term device means an instrument apparatus implement machine and plant in vitro and reagent, or other similar related articles.

59:36.440 --> 59:43.440
He tended for the use in the diagnosis of disease, or in the cure mitigation treatment and prevention of disease.

59:43.440 --> 59:55.440
So that's a huge category of stuff called medical device. And I think that's, I'm having a little trouble with this pen. It's a little new. I don't like the nib.

59:55.440 --> 01:00:03.440
I'm not going to play with it anymore. I have been a long time since I've been annoyed by a pen. That was really annoying.

01:00:03.440 --> 01:00:05.440
Shoot.

01:00:05.440 --> 01:00:18.440
Strike out on the new pen. Go back to the Jedi master. And so, yeah, so what was I saying medical device? Well, I can be distracted very easily by my pen.

01:00:18.440 --> 01:00:32.440
The medical device as an idea is what he actually was stating was medical device as a legal concept. And so I think it's good for us to just go back a few seconds and make sure.

01:00:32.440 --> 01:00:35.440
Hear that.

01:00:35.440 --> 01:00:40.440
Oh boy, I hope I didn't screw it up.

01:00:40.440 --> 01:00:42.440
Maybe I have to play it.

01:00:42.440 --> 01:00:44.440
And then it'll do it.

01:00:44.440 --> 01:00:49.440
So I'm going to sit in and how you go from an EOA.

01:00:49.440 --> 01:00:54.440
Surveillance signals.

01:00:54.440 --> 01:01:09.440
Just as a way of a brief overview of medical device regulations and where you ways fit in and how you go from an EOA to a fully authorized device. I wanted to go through a few of these steps now.

01:01:09.440 --> 01:01:13.440
So this list, the definition of a medical device.

01:01:13.440 --> 01:01:35.440
Section 201 H states the term device means an instrument apparatus, implement machine, confinement and plant in vitro and reagent or other similar related articles. That's a long list for the use in the diagnosis of disease, or in the cure mitigation treatment and prevention of disease, etc.

01:01:35.440 --> 01:01:43.440
You know, what are IVDs. They are reagents, instruments and systems intended for the use and diagnosis of disease.

01:01:43.440 --> 01:01:50.440
And, and on specimens taken from the human body.

01:01:50.440 --> 01:01:52.440
So here at the FDA.

01:01:52.440 --> 01:01:54.440
Well, I think that's interesting.

01:01:54.440 --> 01:01:58.440
That's a very important.

01:01:58.440 --> 01:02:16.440
That's a very important thing that he said there. I guess I didn't have to make myself disappear using specimens from the human body.

01:02:16.440 --> 01:02:25.440
That's a very specific thing, right? It's using specimens from the human body to diagnose stuff.

01:02:25.440 --> 01:02:40.440
That's a very specific kind of medical device, which is a much larger category of stuff that is regulated by the FDA. So we are now talking about IVDs, which was also the subject of the whole discussion.

01:02:40.440 --> 01:02:55.440
So we understand now the imperative here. What's so incredible. They're not talking about novel novel repurposed drugs. They're not talking about anything other than diagnostics.

01:02:55.440 --> 01:03:01.440
The NQ tell lady talked about diagnostics, diagnostics, diagnostics, diagnostics defined.

01:03:01.440 --> 01:03:05.440
We can even go back to those notes because that's why we have a notebook.

01:03:05.440 --> 01:03:12.440
Where is it evaluating? Oh, I wrote that a lot trying to test that pen.

01:03:12.440 --> 01:03:16.440
It's too bad that pen sucks. Wow. It's too bad.

01:03:16.440 --> 01:03:21.440
Where is it testing for natural immunity? No, that was the thing before.

01:03:21.440 --> 01:03:24.440
What's up.

01:03:25.440 --> 01:03:32.440
Oh, hey. Yeah.

01:03:32.440 --> 01:03:37.440
Where did I put that list? Imagine how valuable it can't be more valuable.

01:03:37.440 --> 01:03:41.440
Diagnostics. Oh, yeah, it's right here. Sorry. And I wrote all over it.

01:03:41.440 --> 01:03:46.440
So in that video, this is not going to help because I was testing a pen here.

01:03:46.440 --> 01:03:50.440
Hopefully there's no swear words in between.

01:03:50.440 --> 01:03:55.440
Yeah. Anyway, they talked about the six times that they that they gave out.

01:03:55.440 --> 01:04:00.440
Then they talked about diagnostics being key. That's what they did. Now I'm testing a pen here.

01:04:00.440 --> 01:04:04.440
So I'm not going to show you these notes. That's a little annoying. I apologize.

01:04:04.440 --> 01:04:12.440
But that was the NQ tell lady saying diagnostics, diagnostics, diagnostics, then the lady from Ebola comes on and says that diagnostics has all I do.

01:04:12.440 --> 01:04:18.440
Then, and she worked for the FDA, then, or did she?

01:04:18.440 --> 01:04:35.440
I wish she was CDC. I don't remember. Then we come on with this talk and the first lady is only talking about the rear admils only talking about diagnostics and establishing the standards by which new diagnostics can be evaluated.

01:04:35.440 --> 01:04:44.440
So that's interesting. And now we come to this guy who's now talking about IVDs and defining them. So we're getting down now into how it's done.

01:04:45.440 --> 01:04:56.440
FDA classifies them as a medical device that they regulate as a medical device and an IVD is defined as a him vitro diagnostic that specifically uses a specimen from the human body.

01:04:56.440 --> 01:04:59.440
All right, go.

01:04:59.440 --> 01:05:07.440
A new developed test to come through the agency and they're divided into class one, two and three, three being the hottest risk.

01:05:08.440 --> 01:05:10.440
And requiring a PMA.

01:05:10.440 --> 01:05:23.440
There are low class class one low risk devices. Many of these, at least in our office, have have already been exempted from the market review. There are a subset that do still require either 510 K or denial.

01:05:24.440 --> 01:05:39.440
The middle are class class two of moderate and controlled risk devices is the one we'll largely focus on in discussions today because this is the pathway through which most eways will come through and they'll come through first.

01:05:39.440 --> 01:05:42.440
First one will come through the general pathway.

01:05:42.440 --> 01:05:51.440
So then now he's already saying that there are three classes of devices depending on, I guess, their perceived potential for harm.

01:05:51.440 --> 01:05:59.440
And again, we're already seeing how the bureaucratic loopholes have been already perfectly set.

01:05:59.440 --> 01:06:16.440
So that a potential for a diagnostically fueled pandemic illusion to be allowed to happen funded and allowed to happen just based on the fact that those doors are right now those doors are open.

01:06:16.440 --> 01:06:33.440
The regulatory doors of the FDA are wide open for this to occur in the event of an emergency and he's explaining with very big complicated words to people only who have sufficient insight into how this system functions would know what he's talking about.

01:06:33.440 --> 01:06:37.440
Otherwise it's just going over their head three classes of devices that make sense, Bob.

01:06:37.440 --> 01:06:51.440
What we are about to hear is why eways for diagnostics can be basically given out by one person in an office who reads the application and says yes okay, which is really crazy if you think about it.

01:06:51.440 --> 01:07:02.440
Imagine if we defined a new disease based on the fact that you wanted to make a product to test for it and this one guy over here said yes sure go ahead.

01:07:02.440 --> 01:07:12.440
There's no standards. So how can we really evaluate it anyway at this time. Do you see this particular nature of this?

01:07:12.440 --> 01:07:18.440
It's, it's, it's not something to be underestimated how important this is.

01:07:18.440 --> 01:07:22.440
The equipment similar devices will come through the five times.

01:07:22.440 --> 01:07:27.440
In part of that to novel process there will be special controls that will be written.

01:07:27.440 --> 01:07:31.440
I'm sure here a lot more about that.

01:07:31.440 --> 01:07:35.440
So to focus right on the novel process.

01:07:35.440 --> 01:07:42.440
And this is the process that has been recently used for some of the devices that have come through the.

01:07:42.440 --> 01:07:51.440
So it is a pathway from a novel load of moderate risk devices, where there is no predicate device in which to compare performance.

01:07:51.440 --> 01:07:57.440
There is a new for goal for FDA review time of of denobos.

01:07:57.440 --> 01:08:03.440
So we take that very seriously in our office is being really excellent at meeting that.

01:08:03.440 --> 01:08:11.440
And so what I think you're hearing here is that the term denovo process and he's repeating device over and over again because he wants to accentuate.

01:08:11.440 --> 01:08:27.440
The legal fact that the FDA can only regulate regulate these as devices and they are class two devices and going through a de novo process because these devices don't have a precursor there's no, there's no previous existing product.

01:08:27.440 --> 01:08:35.440
There's nothing to evaluate them on the basis of this is completely de novo.

01:08:36.440 --> 01:08:45.440
So I mean, you know, there's a new virus. I mean, well, how would we know whether these things work or we just have to let them all go I guess.

01:08:45.440 --> 01:08:48.440
See what sticks.

01:08:48.440 --> 01:09:01.440
This is an incredibly lacking of energy presentation with huge legal words repeated over and over again purposefully like device device device.

01:09:01.440 --> 01:09:08.440
Because he wants you to understand that this is how it's going to go and unregulated through the road.

01:09:08.440 --> 01:09:10.440
I'm going to beat it wherever possible.

01:09:10.440 --> 01:09:18.440
So what does the application require what cause probable benefits that outweigh risk and also.

01:09:19.440 --> 01:09:30.440
Meeting general and the specific controls that are written for this new regulatory classification in order to provide that device is safe and effective.

01:09:30.440 --> 01:09:36.440
If marketing is granted a new regulation is created either the class one or class two device.

01:09:36.440 --> 01:09:45.440
And then that device can serve as a predicate for all subsequent devices that are submitted to FDA and then we make our decision summaries public.

01:09:45.440 --> 01:09:55.440
So that's available to all. So they use the decision on one as a predicate for all the others. So there's actually no accountability.

01:09:55.440 --> 01:10:05.440
The first EUA granted for a PCR test without controls or validation possible in an emergency will just be the precedence so that anyone can do it.

01:10:05.440 --> 01:10:22.440
Maybe even a porn producer could decide to buy $400,000 worth of full genome sequencing capable equipment that would only really be useful in a university core facility and get a contract to sequence all of the municipal employees of a west coast town.

01:10:22.440 --> 01:10:27.440
Make millions of dollars by three houses. Why not right.

01:10:27.440 --> 01:10:32.440
I mean if if this is going to be this easy.

01:10:32.440 --> 01:10:49.440
How many more examples of there of that in Pittsburgh or in Philadelphia or in Massachusetts or in Oregon or anywhere in the United States where people were tipped off that this is the way.

01:10:49.440 --> 01:10:54.440
Because I assure you people were tipped off that this was the way.

01:10:54.440 --> 01:11:16.440
The only way that this works you want your want your on ramp to the ruling elite. This was the on ramp that was offered to a lot of people to the ruling elite be a part of it.

01:11:17.440 --> 01:11:24.440
What we required and what what the performance was in that device.

01:11:24.440 --> 01:11:27.440
I'm just going to check with you.

01:11:27.440 --> 01:11:43.440
If you can authorize under this legislation use of unapproved medical countermeasures and underpreve uses of approved medical countermeasures to diagnose treat or prevent serious or life or diseases or conditions.

01:11:43.440 --> 01:11:55.440
It's too important to highlight that anyway is not a substitute or shortcut to a full approval or a clearance.

01:11:55.440 --> 01:12:02.440
And that when scientific evidence is available support medical countermeasures.

01:12:02.440 --> 01:12:19.440
Between you may enables a response to stakeholders to use and how to use this particular device or devices without violating the food and drug and cosmetic act.

01:12:19.440 --> 01:12:39.440
To date on the agency is authorized 57 or so on the way of those six have progressed through the door will or 510 so you can see that only about 10% have achieved full marketing authorization.

01:12:39.440 --> 01:12:47.440
Some of those challenges and barriers and have been already fully expressed this morning.

01:12:47.440 --> 01:12:55.440
We would like to examine ways that we can remove some of those barriers that more of these devices can come through the snowball and 510.

01:12:56.440 --> 01:13:09.440
Just to highlight a recent publication that expresses, you know, some of the concerns in this case in several items cases, it's required to samples be destroyed in seven days.

01:13:09.440 --> 01:13:26.440
So if you can't even create a bank of samples that could be subsequently used to develop and validate a test, you know, how are you going to go about doing this sort of work.

01:13:26.440 --> 01:13:31.440
So that's why you'll hear more about real world data and real world evidence.

01:13:31.440 --> 01:13:37.440
So that is one of the potential solutions, of course during the outbreak.

01:13:37.440 --> 01:13:38.440
All attention is on.

01:13:39.440 --> 01:13:48.440
So what he's already he's already hinting at is the idea that we can't test this stuff because samples need to be destroyed.

01:13:48.440 --> 01:13:58.440
So we can't build a database we can't build a a repository with which we can use to develop these these new devices.

01:13:58.440 --> 01:14:07.440
And so you're going to hear more and more about real world data, which really what he means is we're going to roll the devices out and then see if they're useful.

01:14:07.440 --> 01:14:14.440
Try to evaluate them on the background of their use during the pandemic. That's what he's saying here.

01:14:14.440 --> 01:14:23.440
And of course you know that won't work, especially if they already have characterized the background, then they know that won't work as well.

01:14:23.440 --> 01:14:29.440
And it all depends on whether or not the test is specific for a background that exists or not.

01:14:29.440 --> 01:14:31.440
And they have to know that.

01:14:31.440 --> 01:14:42.440
And so here we are where you are more or less seeing right down the throat of the beast here with people just being told that this is about to happen.

01:14:42.440 --> 01:14:52.440
This is the way we're going to do it. We do not care. We want to get as many of these things across the approval finish line as possible.

01:14:52.440 --> 01:15:08.440
No questioning the need. No questioning the possible dangers of having a diagnostic set of tools out there that has a questionable at best unproven effectiveness at following whatever they're supposed to follow.

01:15:08.440 --> 01:15:22.440
And the horrible repercussions of that should there be protocols that are financially tied to these less than optimal diagnostics. It's an extraordinary level of malevolence that's being laid down here right now.

01:15:22.440 --> 01:15:31.440
You're seeing the dominoes being stacked.

01:15:31.440 --> 01:15:42.440
He doesn't look very comfortable meeting as we are today with the current meeting our mission objectives to protect and promote public health.

01:15:42.440 --> 01:16:00.440
Secondary is the thought to the longer term authorizations. So, however, if we can lay down pathways using real world data real world evidence so that there isn't the inhibition to use this kind of information.

01:16:00.440 --> 01:16:13.440
And also currently in a four market authorization. That's one of the clear barriers perhaps that we can move or at least shorten.

01:16:13.440 --> 01:16:29.440
Of course, we've already issued final guidance in this area. And the importance of the relevance and the reliability of the data are all important here. Is it a FDA regulatory quality. So that's where our focus would be.

01:16:30.440 --> 01:16:38.440
Some of the devices and real logical house at the FDA has a risk based approach to regulation of medical devices, including IVDs.

01:16:38.440 --> 01:16:43.440
Genoa is the pathway for novel low risk and moderate risk devices.

01:16:43.440 --> 01:16:48.440
EOA is not a substitute or a shortcut to full authorization.

01:16:48.440 --> 01:16:59.440
And all office within CDRH as well as really the support of the rest of the agency is committed to working with all stakeholders to advance EOA products to full marketing status.

01:16:59.440 --> 01:17:06.440
And I thank you for coming today.

01:17:07.440 --> 01:17:25.440
The FDA was to protect and promote public health, which is funny. I thought they were mainly supposed to make sure that the label said what it meant, and meant what it said, but I could be wrong. So who's this guy.

01:17:25.440 --> 01:17:35.440
Great.

01:17:35.440 --> 01:17:49.440
Yeah, good morning. Thank you for the opportunity to be here this morning and share with you some of the approaches transition diagnostics from emergency use authorization to market application.

01:17:49.440 --> 01:17:53.440
Am I, I'm just going to say, why do we have a German guy.

01:17:53.440 --> 01:17:57.440
What is his title? He was the head of

01:17:57.440 --> 01:18:08.440
going on here. Hold on a minute. I just want to find out what this guy is again. I know I had it written somewhere.

01:18:08.440 --> 01:18:17.440
Oovei

01:18:18.440 --> 01:18:21.440
Sheriff.

01:18:21.440 --> 01:18:27.440
So what is his deal?

01:18:27.440 --> 01:18:32.440
I don't really get it. I don't know why.

01:18:32.440 --> 01:18:41.440
Sure.

01:18:41.440 --> 01:18:54.440
So he's deputy director at FDA CDRH OIR DMD, which is deputy director of division of microbiology devices.

01:18:54.440 --> 01:19:01.440
And he's been that deputy director since 2004.

01:19:01.440 --> 01:19:07.440
So for 20 years, this guy's worked for the FDA.

01:19:07.440 --> 01:19:15.440
I wonder when he came to the United States obviously didn't go to school in the United States or his accent wouldn't be so thick.

01:19:16.440 --> 01:19:28.440
And he does research and development for a company called gene logic, which I guess doesn't exist anymore or something like that. That's all I can see on LinkedIn.

01:19:28.440 --> 01:19:30.440
Interesting.

01:19:31.440 --> 01:19:36.440
Regent University of a sheriff is a different guy. Okay. That's a different person.

01:19:36.440 --> 01:19:41.440
And FDA. Oh, this is a.

01:19:41.440 --> 01:19:45.440
This is a.

01:19:45.440 --> 01:19:51.440
Him approving. It's funny. You just get the random letters of his.

01:19:51.440 --> 01:19:55.440
That show up as.

01:19:56.440 --> 01:20:01.440
As EUA approval letters. So here is just a random letter when I search for him.

01:20:01.440 --> 01:20:05.440
It was just one of these things right here. Right. See.

01:20:05.440 --> 01:20:08.440
Click on that and you get.

01:20:08.440 --> 01:20:22.440
This is to notify you that request to update the shelf life expiration date of the care start COVID-19 antigen test to 12 months at one to 30 degrees C based on the results of your real time stability study.

01:20:22.440 --> 01:20:28.440
I E. Were they any good after we didn't storm cold? His granted upon review.

01:20:28.440 --> 01:20:34.440
We concur that the data and information submitted. So we is a sheriff.

01:20:34.440 --> 01:20:50.440
So he is the guy who can just decide if this stuff can be rolled out against thousands of people sold for thousands of dollars to point of care places and used to generate data as to whether there was a pandemic or not.

01:20:50.440 --> 01:20:55.440
This guy from Germany is going to be the dude who does this just writes out these letters.

01:20:55.440 --> 01:20:59.440
We decided your EUA is granted.

01:20:59.440 --> 01:21:06.440
Here he is. This is the guy who grants you a for diagnostic tests in America.

01:21:06.440 --> 01:21:13.440
This is the guy right here.

01:21:14.440 --> 01:21:29.440
In the overview of my presentation here. So I will first review the EUA authorization authority and then describe to you and in EUA versus pre market study requirements.

01:21:29.440 --> 01:21:37.440
And we'll finish up with introducing to you the guidance on the real world evidence and real world data.

01:21:37.440 --> 01:21:41.440
Wow. It's exactly what it says in that letter.

01:21:41.440 --> 01:21:48.440
So the EUA authority is described under 564 of the Food, Drug and Cosmetic Act.

01:21:48.440 --> 01:21:56.440
And it allows FDA to strengthen the nation's public health protections against biological.

01:21:56.440 --> 01:22:09.440
Chemical, radiological and nuclear threats by facilitating the availability to use medical countermeasures, eating during a public health emergency.

01:22:09.440 --> 01:22:16.440
The original act has been amended several times as listed here.

01:22:17.440 --> 01:22:21.440
As Dr. Stancher mentioned earlier.

01:22:21.440 --> 01:22:35.440
In public health emergency with the emergency use authorization FDA can authorize the use of an unapproved product as well as an unapproved use of an approved product.

01:22:35.440 --> 01:22:47.440
This is only possible under certain or in certain criteria are met and it will go to this criteria later on.

01:22:47.440 --> 01:22:55.440
As you know, in vitro diagnostic space are extremely important role in the emergency involving an emerging infectious disease.

01:22:55.440 --> 01:23:02.440
In the very beginning where we are now into the diagnosis, patient management and infection control.

01:23:02.440 --> 01:23:18.440
And in the absence of a cleared or approved essay, the FDA authority, the way authorities and mechanism for FDA to use to address this public health emergency.

01:23:18.440 --> 01:23:29.440
This slide shows the six active determinations and declarations for in vitro diagnostics from 2013 to now.

01:23:30.440 --> 01:23:44.440
And each seven and nine most corona, Ebola, the antivirus D 68 Zika virus as of this weekend, also the novel coronavirus.

01:23:44.440 --> 01:23:52.440
Here I summarize for you the scenarios that can lead to an emergency use authorization.

01:23:52.440 --> 01:24:09.440
The determination of an emergency, this is significant, its emergency or significant potential of an emergency can be made by first the secretary of DOD by military emergencies.

01:24:09.440 --> 01:24:18.440
Second, the secretary of DHS for domestic emergencies and indications for material threats.

01:24:18.440 --> 01:24:25.440
And for this by the secretary of HHS for public health emergencies.

01:24:25.440 --> 01:24:33.440
The secretary then declares that circumstances exist to justify emergency use authorization.

01:24:33.440 --> 01:24:44.440
The emergency emergency has been declared by the secretary, the FDA commissioner can authorize devices if the criteria for issuance are met.

01:24:44.440 --> 01:24:52.440
The assessment is done in consultation with ASPA, CDC and NIH.

01:24:52.440 --> 01:25:02.440
This slide shows the main criteria that need to be met to allow an authorization of a device under the EU authorization.

01:25:02.440 --> 01:25:09.440
First, the agent in question causes a serious or life threatening disease or condition.

01:25:09.440 --> 01:25:18.440
Second, based on reasonable assurance of the scientific evidence.

01:25:18.440 --> 01:25:34.440
Okay, so agent causes disease.

01:25:34.440 --> 01:25:41.440
The product may be effective and the known potential benefits outweigh the known.

01:25:41.440 --> 01:25:45.440
So agent causes disease.

01:25:45.440 --> 01:25:56.440
Product and maybe we should say device may be effective.

01:25:56.440 --> 01:26:00.440
And three, what did he say?

01:26:00.440 --> 01:26:07.440
Potential risks. Oh yeah, that benefits.

01:26:07.440 --> 01:26:13.440
Outway risks.

01:26:13.440 --> 01:26:18.440
So these are the general reasons why the FDA would give a.

01:26:18.440 --> 01:26:23.440
An EUA after an emergency was declared either by DOD or HSHS.

01:26:23.440 --> 01:26:27.440
That's what he's saying right now.

01:26:27.440 --> 01:26:31.440
Third, no adequate approved.

01:26:31.440 --> 01:26:36.440
Available alternative to the market is available.

01:26:36.440 --> 01:26:42.440
The benefits and the risks are assessed for each request independently.

01:26:42.440 --> 01:26:50.440
Based on the circumstances as a time of the intended authorization.

01:26:50.440 --> 01:27:03.440
Next, I would like to provide for you a summary of the program within FDA and steps sponsors can take when submitting the EUA device.

01:27:03.440 --> 01:27:07.440
I would like to point out the three points.

01:27:07.440 --> 01:27:10.440
The pre a submission.

01:27:10.440 --> 01:27:18.440
The template and sponsor and FDA interactions, which occur multiple times.

01:27:18.440 --> 01:27:26.440
These activities and tools can be used before and after the emergency is declared.

01:27:26.440 --> 01:27:31.440
They're designed to streamline the data acquisition and regulatory review.

01:27:31.440 --> 01:27:36.440
Sponsors are encouraged to act with us early.

01:27:36.440 --> 01:27:41.440
Especially when bio threat and emergent infections are concerned.

01:27:41.440 --> 01:27:48.440
After the emergency has been declared, when the study results are supportive of an authorization.

01:27:48.440 --> 01:27:52.440
The EUA is converted to a pre a is converted to a area.

01:27:52.440 --> 01:27:58.440
Other FDA offices might get involved in the final steps from that organization.

01:27:59.440 --> 01:28:01.440
So there might be additional interactions.

01:28:01.440 --> 01:28:07.440
However, usually at this point an authorization is expected.

01:28:07.440 --> 01:28:11.440
After the device has been authorized sponsors can.

01:28:11.440 --> 01:28:16.440
So we're already talking about full authorization for testing full authorization for diagnostics.

01:28:16.440 --> 01:28:22.440
We're not talking about we're talking about rushing in with as many of these as possible.

01:28:22.440 --> 01:28:32.440
We're talking about streamlining the data acquisition, the real time data acquisition in order to get full authorization as quickly as possible.

01:28:32.440 --> 01:28:35.440
So they're never going to do trials on these things.

01:28:35.440 --> 01:28:50.440
That was never the intention. The intention was to use the rollout, the successful application to the ongoing pandemic as sufficient evidence that they are of of minimal harm.

01:28:50.440 --> 01:28:56.440
It's only about minimal harm. It has nothing to do with their specificity as a diagnostic.

01:28:56.440 --> 01:29:02.440
Benefits just have to outweigh the risk. And if a test is just a test, it's not going to hurt anybody.

01:29:02.440 --> 01:29:07.440
This is where we are. It's better to have false positives than not know.

01:29:07.440 --> 01:29:11.440
Oh my goodness, it's, it's crazy.

01:29:11.440 --> 01:29:18.440
Interact with FDA to add new specimen types, extraction methods, instruments and so on.

01:29:19.440 --> 01:29:22.440
The documents that you can see here.

01:29:22.440 --> 01:29:33.440
They are generated through the process are generated to help expedite the development and validation for devices for other sponsors.

01:29:33.440 --> 01:29:52.440
The EU EU EU template, as well as the publicly available letter of authorization, the fact sheet for healthcare providers and for patients, and we've manufactured package insert or instructions for use.

01:29:52.440 --> 01:30:02.440
Next, I will summarize for you all the key differences between you and pre market submissions.

01:30:02.440 --> 01:30:18.440
This table should compare the requirements in terms of special circumstances, duration, analytical evaluation, typically evaluation, and good manufacturing practices.

01:30:19.440 --> 01:30:26.440
As mentioned earlier, in EU a requires a declaration of emergency by HHS.

01:30:26.440 --> 01:30:38.440
The duration of the use of the device is temporary remains only in effect for the duration of the declaration unless we work earlier.

01:30:38.440 --> 01:30:44.440
This is different to unlimited conditions for authorized or cleared devices.

01:30:45.440 --> 01:30:55.440
Analytical and clinical evaluations are somewhat limited for us, but still require to demonstrate acceptable performance.

01:30:55.440 --> 01:30:58.440
Pre market submission require full validation.

01:30:58.440 --> 01:31:12.440
With manufacturing practices, I expected for both, but certain requirements, including the quality system requirements, can be waived for us, but are required for pre market submission.

01:31:13.440 --> 01:31:20.440
I want to stress that the requirements for the de novo IVDs are subject to general and special controls.

01:31:20.440 --> 01:31:35.440
And they are described in detail in the de novo classification orders and decision summaries that can be found at the list of web page here.

01:31:35.440 --> 01:31:38.440
This slide gives an example that outlines the study.

01:31:38.440 --> 01:31:48.440
And so he's already just said the EU is needs an emergency. It's a temporary declaration. It's a limited evaluation, though. They don't have any way of evaluating these things.

01:31:48.440 --> 01:31:53.440
So they don't have to be validated as being working.

01:31:53.440 --> 01:31:57.440
And quality control measures can be waived.

01:31:57.440 --> 01:32:01.440
Because it's an EUA. We don't have any way of it. It's too.

01:32:01.440 --> 01:32:10.440
But quality control is required in pre market submissions. Full validation is required in a pre market submission for.

01:32:10.440 --> 01:32:26.440
For approval, but if you get an EUA during an emergency, anything can be rolled out and real time data can be gathered quote unquote, which can be submitted and bypass all of this full validation that would have normally been required.

01:32:26.440 --> 01:32:42.440
And here we have a German national who's been seated at a very nice and cushy job at the FDA for 20 years telling us these things in a German accent.

01:32:43.440 --> 01:32:51.440
What if it turned out that that you were to do some kind of research on this guy and find out that he had a house by the FDA where he worked.

01:32:51.440 --> 01:33:02.440
He had a house in Frederick, Maryland, and he had a house on the beach in Delaware while he was doing all this incredible work at the FDA for these years.

01:33:02.440 --> 01:33:07.440
He doesn't own all those houses now, but he did for a very long time.

01:33:07.440 --> 01:33:19.440
He was in Frederick, Maryland, a house on the beach in Delaware and a house somewhere in Maryland to work for the FDA.

01:33:19.440 --> 01:33:27.440
Strange people are in this theater, ladies and gentlemen, I don't know who this guy is. I just found him in this video.

01:33:27.440 --> 01:33:30.440
What is he doing?

01:33:30.440 --> 01:33:38.440
Why does he have the power to allow a a testing lab to exist?

01:33:38.440 --> 01:33:56.440
How does this guy uve sheriff is his name? How does he have the power to grant an EUA to a diagnostic test for a novel disease just because he's got a LinkedIn page that says he's worked for the FDA for 20 years and he can write on on their digital

01:33:56.440 --> 01:33:59.440
letterhead.

01:33:59.440 --> 01:34:03.440
This is all it took one guy.

01:34:03.440 --> 01:34:10.440
One guy is enabling the EUA of these things, not his department.

01:34:10.440 --> 01:34:15.440
He didn't even sign that letter. It's just a digital thing.

01:34:15.440 --> 01:34:22.440
He couldn't even be bothered to insert a digital signature.

01:34:22.440 --> 01:34:28.440
And there are hundreds of letters like that online that I encourage you to collect and send to me so that I don't have to do it myself.

01:34:28.440 --> 01:34:34.440
I want to find every letter of EUA adjustment or approval that he ever wrote.

01:34:34.440 --> 01:34:40.440
Because I just find it really interesting. Why this guy? Who is this dude? Why is it this dude?

01:34:40.440 --> 01:34:44.440
It's required for an EUA in comparison to pre-market submissions.

01:34:44.440 --> 01:34:52.440
I selected the example of a new click asset based test because they are the majority of EUA applications we obtain.

01:34:52.440 --> 01:34:53.440
I see.

01:34:53.440 --> 01:34:57.440
First, the limit of detection.

01:34:57.440 --> 01:35:02.440
This is an essential study method to understand the performance of the device.

01:35:02.440 --> 01:35:09.440
The LOD studies are basically the same for EUAs in pre-market applications.

01:35:09.440 --> 01:35:17.440
LOD studies are usually performed in each claim specimen type, following CLSI standards.

01:35:17.440 --> 01:35:31.440
When possible, reference material for traceability purposes should be tested when they come available by colleague, but the page later on in the afternoon will provide additional detail on this concept.

01:35:31.440 --> 01:35:37.440
In facility studies, wet testing is needed.

01:35:37.440 --> 01:35:43.440
For mad essays, additional in silico evaluation has been successfully used.

01:35:43.440 --> 01:35:58.440
In silico evaluation has the advantage to use multiple analysis tools and all available relevant genomic information, being complementary, comprehensive and fast.

01:35:59.440 --> 01:36:13.440
The comprehensive and fast in silico evaluation essentially, what Robert Malone did with three weeks and a volunteer team that he spun up after Michael Callahan called him from Wuhan and said you better get to work.

01:36:14.440 --> 01:36:32.440
He used an in silico model of the three CL protease to interface with, I guess, other in silico models of all known pharmaceuticals and nutraceuticals in the FDA catalog to identify remdesivir.

01:36:32.440 --> 01:36:49.440
To identify Ivermectin, to identify silicoxib and to identify femotidine has four potential treatments for this novel virus and its three CL protease.

01:36:49.440 --> 01:37:00.440
Not the RNA dependent RNA polymerase, not the 28 other odd proteins that we don't really understand very well apparently.

01:37:00.440 --> 01:37:13.440
But for the three L three CL protease, they all agreed on that. That was part of their narrative in silico evaluation means using computer models.

01:37:13.440 --> 01:37:23.440
And he repeats it a couple times because he wants to make sure the people that understand the code get it. But essentially, if there's no reference material, you can make up a computer model and do it that way.

01:37:23.440 --> 01:37:41.440
And you can use all the genetic reference material to justify it and all your previously existing models that you can tweak however you want, use those all to validate your using in silico evaluation so that we can get your EUA test to full market status.

01:37:41.440 --> 01:37:44.440
This is incredible stuff.

01:37:44.440 --> 01:37:48.440
This is a situation specific for our EUA's.

01:37:48.440 --> 01:37:55.440
A precision study is not required for an EUA, but for authorized or clear devices performance.

01:37:55.440 --> 01:37:59.440
A precision study is not required for an EUA.

01:37:59.440 --> 01:38:06.440
Listen carefully because he says it out loud.

01:38:06.440 --> 01:38:27.440
A precision study is not required for an EUA, but for authorized or clear devices performance need to be generated at three different sites.

01:38:28.440 --> 01:38:44.440
I mean, think about that. The precision necessary for a pre market submission, you have to show that it can be made in three separate sites at the same level of quality.

01:38:44.440 --> 01:38:51.440
And this person says that that's not at all necessary for an EUA. It's extraordinary.

01:38:51.440 --> 01:39:07.440
However, alternative options can be considered in consultation with FDA, depending on the availability of the material at the time of the validation studies.

01:39:08.440 --> 01:39:19.440
This table summarizes for you all the authorized devices between 2013 and now the transitioned to fully validated products.

01:39:19.440 --> 01:39:25.440
The data shown here are for the devices with active EUA declarations.

01:39:25.440 --> 01:39:36.440
The top row shows the number of original authorized operations for each viruses, a total number of 39 products were authorized.

01:39:36.440 --> 01:39:45.440
The second row shows the number of EUA reauthorizations and granted amendments after the original authorization.

01:39:45.440 --> 01:39:53.440
A total of 18 EAs were reauthorized and 16 were granted amendments.

01:39:53.440 --> 01:40:06.440
And so the incredible thing is that after the first year and a half, there were more than 200 EUA granted devices for diagnostics, more than 200 in America.

01:40:06.440 --> 01:40:12.440
So for the previous pandemics, there was a total of 39 with 18 amendments granted.

01:40:12.440 --> 01:40:22.440
And in this first year of the pandemic, more than 200, why would we need more than 200 for all the same virus?

01:40:22.440 --> 01:40:25.440
For all the same novel pathogen.

01:40:25.440 --> 01:40:28.440
Why would we ever allow that?

01:40:28.440 --> 01:40:33.440
Now, we don't know that in February of 2020 that this is going to go bananas.

01:40:33.440 --> 01:40:37.440
We think that, oh, well, he says that there were 30 in the last 15 years.

01:40:37.440 --> 01:40:40.440
So maybe we'll have four or five for this one. That'll be cool.

01:40:40.440 --> 01:40:45.440
No, this whole presentation is about how we want to maximize that.

01:40:46.440 --> 01:40:53.440
We want to maximize your ability to take advantage of the fact that the EUA requires none of these things here.

01:40:53.440 --> 01:40:55.440
None of those are required.

01:40:55.440 --> 01:41:00.440
This pre-market submissions require all those things, but an EUA doesn't.

01:41:00.440 --> 01:41:09.440
And an EUA can even use in-sellico evaluation, which is, of course, completely not allowed for a pre-market submission.

01:41:09.440 --> 01:41:14.440
No precision is required for this one.

01:41:15.440 --> 01:41:23.440
Whereas a pre-market submission would have to show independent places where its device can be made successfully at the same level of quality control.

01:41:24.440 --> 01:41:32.440
These are extraordinary statements being made here by this German national dual citizen, whatever he is with an accent.

01:41:32.440 --> 01:41:48.440
Just following the slides, doing as he's told, rolling out the fact that he's going to give away a bunch of EUAs for diagnostics that he knows cannot possibly work by design because we don't have any standards.

01:41:53.440 --> 01:41:59.440
The last row shows a number of products that actually transitioned to a fully marketed device.

01:41:59.440 --> 01:42:13.440
You can see here we only have six products that made it through the full validation, two for North Carolina, one for Ebola, and three for Quasico.

01:42:13.440 --> 01:42:26.440
To the best of my knowledge, the majority of these fully validated devices were funded by federal resources provided by BADA programs.

01:42:26.440 --> 01:42:30.440
So, BADA did all the six products that have made it past the test.

01:42:30.440 --> 01:42:40.440
So, of all the other products, the 36 other products, I guess all 30 of them weren't very good or something like that, right?

01:42:40.440 --> 01:42:42.440
That's what the assumption can be made.

01:42:42.440 --> 01:43:01.440
So now we have a certain number of products, how many of them were available during 2020 and 2021, almost none, which means the pandemic was basically fueled by created by the illusion created by a bunch of EU products, many of which were granted their EUA by this single man,

01:43:01.440 --> 01:43:04.440
and a sheriff.

01:43:04.440 --> 01:43:15.440
And I guess a few other colleagues, because he works at the Department of Microbiology it's not even it's not even in the same FDA building is a lot of this other stuff.

01:43:15.440 --> 01:43:28.440
So in the last, in the next part of my talk, I will summarize some key aspects of FDA guidance on the use of real world evidence that is pertinent to our workshop today.

01:43:28.440 --> 01:43:39.440
I think I'm going to break really quick here I'm going to take the voice to the gym and I'm going to come back in the afternoon after dinner and continue this then tomorrow I've got a lot more work to do as well.

01:43:39.440 --> 01:43:47.440
We've got a lot of stuff that built up over the last four days that we need to go through and so I got a lot of things to do but I got to keep in the shift here.

01:43:47.440 --> 01:44:03.440
This was at least a little bit useful and and and lays a groundwork for for what how we should be thinking about this going forward we need to mine early 2020 for all of the evidence of the momentum and of the, the illusion of consensus

01:44:04.440 --> 01:44:19.440
being seated inside of the bureaucracy to make sure that everybody was lined up and facing the right direction. You cannot underestimate how important it was that these people were all lined up and facing the right direction when necessary.

01:44:20.440 --> 01:44:33.440
I'll try to be back on right after dinner which will be like seven thirty or eight o'clock and we'll do another half an hour 45 minutes of this and then tomorrow I will be on again.

01:44:34.440 --> 01:44:50.440
I apologize again for the last few days being off but it is one of those one of those things where again because the stream is not yet something that keeps keeps everybody fed in the house it is.

01:44:50.440 --> 01:45:00.440
I mean obviously I can't think enough the people that I put on the screen right now because again this stream is funded by these people.

01:45:00.440 --> 01:45:12.440
But if you do the math right now we're looking at about $1,400 a month or so that we make on a good month when everybody gets but there's lots of different subscriptions and stuff like that.

01:45:12.440 --> 01:45:23.440
So I'm very, very happy with that state of affairs but every once in a while I'm going to have to do other things and that might mean a couple days off or three days off and production levels will drop.

01:45:23.440 --> 01:45:40.440
And I swear as soon as we get to the stage where these fumes are enough to keep the train chugging then all bets are off and I'm going to be on here as often as possible including trying to get some of these courses that we've been talking about for a while rolling.

01:45:40.440 --> 01:45:56.440
So as soon as it's all able to be done it's going to be done it might be a combination of me hustling in the background and making enough money to make it possible and it might also be possible it might also be just a couple really good Samaritans supporting us month by month

01:45:56.440 --> 01:46:03.440
and getting enough of those people and I do think that we're not looking to make a million subscribers we're not looking for a million views.

01:46:03.440 --> 01:46:16.440
We're actually looking somewhere between 800 and 1000 subscribers and giving us between $5 and $10 a month would already be enough more than enough for us to do something very significant here as a family.

01:46:17.440 --> 01:46:35.440
Please keep in mind that the new website the stream.bio.giggoom.bio excuse me stream.giggoom.bio is there and it is working and that means that we have something we're starting to establish something that's really an independent

01:46:36.440 --> 01:46:43.440
There's no algorithms on that website it's just our work a little bit of Mark's work and anything that we decide to collect there.

01:46:43.440 --> 01:47:01.440
I'm going to start posting some of Matt Briggs's discussions of uncertainty and probability there because I do want to follow up on those lectures with my own kind of contribution to it what I think I'm going to do is try to give some examples of the ideas that he's putting forth that I can find from neurobiology

01:47:01.440 --> 01:47:07.440
and also just try to talk my way through what he's saying so that I can see if I understand it as well as I think I do.

01:47:07.440 --> 01:47:13.440
So all of that stuff is along this infinite list of things that we have to do and I'm going to put more and more time into it.

01:47:13.440 --> 01:47:22.440
As we move forward it's just it's crazy how fast time is flying and how much stuff is happening in the background that's not very pleasant.

01:47:22.440 --> 01:47:25.440
It's not a lot of fun right now.

01:47:25.440 --> 01:47:32.440
I feel like more than ever we are currently paying the price for having stood up for these last four years.

01:47:32.440 --> 01:47:37.440
And so I think more than anything staying power is going to be necessary.

01:47:37.440 --> 01:47:44.440
Endurance is going to be necessary. And so I'm going to try and build more of that as I move forward. So thank you very much.

01:47:44.440 --> 01:47:53.440
We'll see you later again tonight and hopefully starting to build a pattern of predictability here with presence on the Internet Giga Home Biological.

01:47:53.440 --> 01:47:56.440
I'll play out because I know everybody.

01:47:56.440 --> 01:48:01.440
Thanks very much and I'll see you again this evening after dinner.

01:48:14.440 --> 01:48:17.440
Thank you very much.

01:48:44.440 --> 01:48:47.440
Thank you very much.

01:49:14.440 --> 01:49:40.440
Thank you very much.

01:49:44.440 --> 01:49:50.440
Thank you.

01:50:14.440 --> 01:50:20.440
Thank you very much.

01:50:44.440 --> 01:50:50.440
Thank you very much.

01:51:14.440 --> 01:51:20.440
Thank you very much.

01:51:44.440 --> 01:51:50.440
Thank you very much.

01:52:14.440 --> 01:52:20.440
Thank you very much.

01:52:44.440 --> 01:52:50.440
Thank you very much.

01:53:14.440 --> 01:53:20.440
Thank you very much.

01:53:44.440 --> 01:54:02.440
Thank you very much.

01:54:02.440 --> 01:54:13.440
Thank you very much.

01:54:13.440 --> 01:54:20.440
Thank you very much.

01:54:21.440 --> 01:54:24.440
Involved here. His jumper is no good. Too strong.

01:54:24.440 --> 01:54:29.440
And the box out the aura once again gets a piece run out.

01:54:29.440 --> 01:54:31.440
Jalen Stewart can fly.

01:54:32.440 --> 01:54:38.440
Damps and Johnson closes in on Triton Thompson.

01:54:38.440 --> 01:54:44.440
That's the difference. Look, it is so clever. There's steeps.

01:54:44.440 --> 01:54:48.440
Seven issue. Newton can make things happen deep in the shot clock.

01:54:48.440 --> 01:54:50.440
Step back three.

01:54:50.440 --> 01:54:51.440
Come on, man.

01:54:51.440 --> 01:54:52.440
No glass.

01:54:52.440 --> 01:54:53.440
No glass.

01:54:53.440 --> 01:54:54.440
That was nasty.

01:54:55.440 --> 01:54:59.440
Newton, the jumper.

01:54:59.440 --> 01:55:01.440
It's pure.

01:55:01.440 --> 01:55:03.440
That was not really for him.

01:55:03.440 --> 01:55:06.440
Chris, the numbers at the end were as you alluded to.

01:55:06.440 --> 01:55:12.440
I don't know if I've ever seen or recall a dominant.

01:55:12.440 --> 01:55:16.440
He's not big, but a dominant run to a final like they had last year.

01:55:16.440 --> 01:55:18.440
This is what they do also.

01:55:18.440 --> 01:55:19.440
He's the five man.

01:55:19.440 --> 01:55:21.440
The dribble is in screens.

01:55:21.440 --> 01:55:22.440
He'll re-screen.

01:55:22.440 --> 01:55:23.440
There's the roll.

01:55:23.440 --> 01:55:26.440
Redege, a rack attack.

01:55:26.440 --> 01:55:29.440
It's nine of them in the blowout victory over Stetson.

01:55:29.440 --> 01:55:31.440
Nice bounce.

01:55:31.440 --> 01:55:32.440
No foul call.

01:55:32.440 --> 01:55:34.440
Clingan gets a piece of it.

01:55:34.440 --> 01:55:36.440
Luke Hunger couldn't finish.

01:55:36.440 --> 01:55:38.440
Newton the other way in transition.

01:55:38.440 --> 01:55:39.440
Grad transfer.

01:55:39.440 --> 01:55:40.440
Preston.

01:55:40.440 --> 01:55:42.440
One on one with Clingan.

01:55:42.440 --> 01:55:44.440
Bowie really doing a nice job.

01:55:44.440 --> 01:55:46.440
Not giving touches to Bowie.

01:55:46.440 --> 01:55:53.440
Preston tosses it away.

01:55:53.440 --> 01:55:56.440
Stetson the auras in the game for Yukon.

01:55:56.440 --> 01:55:59.440
Diara gets a free look at this guy.

01:55:59.440 --> 01:56:01.440
Who rocks the red?

01:56:01.440 --> 01:56:04.440
The patience of Diara, but once again Clingan.

01:56:04.440 --> 01:56:07.440
Get those puppies up and down.

01:56:07.440 --> 01:56:09.440
Caravan bounces.

01:56:09.440 --> 01:56:11.440
Newton hangs.

01:56:11.440 --> 01:56:13.440
That's in there.

01:56:13.440 --> 01:56:14.440
And the foul.

01:56:14.440 --> 01:56:17.440
Caravan is happy as Italy made it three.

01:56:17.440 --> 01:56:20.440
Twenty-two of the twenty-four points in the paint.

01:56:20.440 --> 01:56:21.440
Bowie.

01:56:21.440 --> 01:56:22.440
Lots of moves.

01:56:22.440 --> 01:56:23.440
Three-three-nine.

01:56:23.440 --> 01:56:24.440
Clingan.

01:56:24.440 --> 01:56:25.440
Three-nine.

01:56:25.440 --> 01:56:27.440
Two for the price of one.

01:56:27.440 --> 01:56:30.440
A monster performance early.

01:56:30.440 --> 01:56:32.440
Missed it from three-point territory.

01:56:32.440 --> 01:56:33.440
Thirty-three-four team.

01:56:33.440 --> 01:56:34.440
Looking for more.

01:56:34.440 --> 01:56:35.440
Diara upstairs.

01:56:35.440 --> 01:56:37.440
Get some more.

01:56:37.440 --> 01:56:43.440
Look at this bench and this team.

01:56:44.440 --> 01:56:45.440
Good job.

01:56:45.440 --> 01:56:46.440
One more.

01:56:46.440 --> 01:56:47.440
You got it.

01:56:47.440 --> 01:56:48.440
That's another block for Clingan.

01:56:48.440 --> 01:56:49.440
That's seven.

01:56:49.440 --> 01:56:50.440
Look at him down the middle.

01:56:50.440 --> 01:56:51.440
Castle done.

01:56:51.440 --> 01:56:52.440
He rises up.

01:56:52.440 --> 01:56:53.440
He's coming.

01:56:53.440 --> 01:56:54.440
Excuse me.

01:56:54.440 --> 01:56:55.440
And move.

01:56:55.440 --> 01:56:57.440
From beginning to end.

01:56:57.440 --> 01:57:00.440
The big fella keeps it in play.

01:57:00.440 --> 01:57:01.440
And the.

01:57:01.440 --> 01:57:02.440
Fifty-one.

01:57:02.440 --> 01:57:03.440
Twenty-seven.

01:57:03.440 --> 01:57:08.440
That is two and a half to go.

01:57:08.440 --> 01:57:10.440
The big fella still.

01:57:10.440 --> 01:57:11.440
Newton.

01:57:11.440 --> 01:57:13.440
For the husky stuff.

01:57:13.440 --> 01:57:16.440
Apparently you did not.

01:57:16.440 --> 01:57:17.440
Newton.

01:57:17.440 --> 01:57:18.440
Scream Johnson.

01:57:18.440 --> 01:57:20.440
Bowie trying to stick with him.

01:57:20.440 --> 01:57:21.440
Newton floated up.

01:57:21.440 --> 01:57:22.440
Johnson.

01:57:22.440 --> 01:57:23.440
Swam it down.

01:57:23.440 --> 01:57:24.440
And got that.

01:57:24.440 --> 01:57:27.440
It is difficult when you're out banned.

01:57:27.440 --> 01:57:30.440
And in the sense out class.

01:57:33.440 --> 01:57:35.440
Apparently you gave me level one.

01:57:35.440 --> 01:57:36.440
Out of ten.

01:57:37.440 --> 01:57:38.440
And in the formura.

01:57:38.440 --> 01:57:39.440
I'm going to bring this.

01:57:39.440 --> 01:57:40.440
Because I'm scared to keep.

01:57:40.440 --> 01:57:41.440
Some of my father.

01:57:41.440 --> 01:57:43.440
He makes this one.

01:57:43.440 --> 01:57:44.440
He's always informed.

01:57:44.440 --> 01:57:45.440
I'm going to watch.

01:57:45.440 --> 01:57:46.440
Almost there.

01:57:46.440 --> 01:57:47.440
Almost there.

01:57:47.440 --> 01:57:48.440
Almost there.