WEBVTT 00:00.000 --> 00:25.980 I think we're going to start again because my wife took the kids to the gym and I missed 00:25.980 --> 00:31.260 the ride by about 30 seconds that's why actually the stream was still on and I was still doodling 00:31.260 --> 00:36.060 because I was trying to figure out where the car went and then I think I just realized 00:36.060 --> 00:43.380 that what happened was my wife took the kids to the gym which means that I can finish this 00:43.380 --> 00:50.340 stream now as a second edition and then do something else after dinner to earn my bread. 00:50.340 --> 00:55.860 So I'm going to go right away back to this and that means that I'll cut over here, I'll 00:55.860 --> 01:10.380 put this one up, I'll get over to this one. 01:10.380 --> 01:14.220 And I will head to the gym after this is over with and meet them after they're done shooting. 01:14.220 --> 01:20.580 So they have this thing, you can look it up on the internet, it's called shoot 360 and 01:20.580 --> 01:25.320 it's a little like workout place just for basketball and they get a half an hour of 01:25.320 --> 01:30.140 shooting on like a rebounding machine and they also get like a half an hour of ball handling 01:30.140 --> 01:35.300 and so they do that by themselves and then after that we play and so usually during that 01:35.300 --> 01:40.060 hour I have a podcast in my ears or something like that and I'm shooting around on the big 01:40.140 --> 01:46.340 gym. So it's a pretty nice place to go because it's also in this giant building that has 01:46.340 --> 01:52.180 a full-size soccer field inside of it and so you just get this kind of very spacious 01:52.180 --> 01:58.860 feeling, it's a giant gym with a giant place to shoot buckets and also it has soccer going 01:58.860 --> 02:02.420 on and stuff so it's kind of like a little funny temple of sport. So that's where they 02:02.420 --> 02:06.740 are now, I've got about 45 more minutes, I think that's all I need to finish this. 02:06.740 --> 02:12.460 So I will escape out of here and we'll just let Uve continue to explain the subtleties 02:12.460 --> 02:19.260 of getting an EUA from the FDA in February of 2020. 02:19.260 --> 02:25.260 The guidance describes FDA's current thinking on this topic and should be reviewed as a 02:25.260 --> 02:33.300 recommendation unless specific regulatory or statutory requirements are cited. The guidance 02:33.300 --> 02:42.740 is applicable to all devices as defined under Section 201 of the Act. As you've seen earlier 02:42.740 --> 02:50.580 in Dr. Tense's presentation, for the purpose of the guidance, real-world evidence is defined 02:50.580 --> 02:59.100 as data relating to patient health status and or delivery of healthcare routinely collected 02:59.100 --> 03:05.420 from a variety of sources. For example, real-world data include data derived from electronic 03:05.420 --> 03:13.300 health records, claims and billing, data from products and disease registries and data gathered 03:13.300 --> 03:19.100 from other sources such as mobile devices. For the purpose of the guidance, real-world 03:19.100 --> 03:26.100 evidence is defined as a clinical evidence regarding the usage and potential benefit 03:26.100 --> 03:31.500 or risk of a medical product derived from analysis of real-world data. 03:31.500 --> 03:41.980 The regulatory context in which real-world evidence may be used, FDA will consider the use of real-world 03:41.980 --> 03:48.780 evidence to support regulatory decision-making for merit devices when it concludes that the data 03:48.780 --> 03:57.020 used to generate the evidence are sufficient quality to inform a supportive, support a particular 03:57.020 --> 04:05.420 decision. Real-world data may potentially be used as some or all of the evidence necessary to 04:05.420 --> 04:12.820 understand medical device performance at different points of the total product life cycle. For 04:12.820 --> 04:20.460 example, real-world data may be used to generate hypothesis to be tested in appropriate clinical 04:20.460 --> 04:29.260 study or be used as evidence for expanding the labeling or to include additional indications for 04:29.260 --> 04:36.100 use. I would like to mention the guidance does not change FDA's standards for regulatory decision 04:36.100 --> 04:43.300 making and in each context we will evaluate whether the available evidence is of sufficient 04:43.300 --> 04:48.660 quality to address the specific. So I assume that he's going to be evaluating it when it comes to 04:48.660 --> 04:54.820 EUAs that he himself has granted and that's where I think this regulatory scheme starts to become 04:54.820 --> 05:00.700 incredibly sketchy because you might think that there might be an ACIP equivalent here but there 05:00.700 --> 05:06.860 isn't there's just this one guy who they sheriff and a maybe a couple equivalents that are able to 05:06.860 --> 05:13.900 give EUAs they make the decision and the context in which that decision could be made is solely 05:13.900 --> 05:21.820 dependent on what he considers good and if it's all real-world data that he makes that decision on 05:21.820 --> 05:27.180 all the better clinical studies can now be based on real-world data that includes data from medical 05:27.180 --> 05:38.780 devices, mobile devices, disease registries and electronic health records. Do you see how a national 05:38.780 --> 05:48.780 security priority could really streamline the use of an electronic health record to cross-reference 05:48.780 --> 05:57.100 and verify a disease registry or cross-reference or verify mobile device data? Do you see where 05:57.100 --> 06:04.220 a national security priority event could put a German-speaking American guy in front of you 06:04.220 --> 06:11.420 telling you that he is the firewall between you and a wholly fraudulent set of diagnostics being 06:11.420 --> 06:15.980 used to create the illusion of a pandemic? This is our firewall right here, this guy 06:18.540 --> 06:23.580 and his angry presentation that he's being seems to be forced to being given right now. It's 06:23.580 --> 06:27.820 extraordinary regulatory decision being made. 06:36.860 --> 06:43.020 So what are the characteristics for real-world data to support particular regulatory decisions? 06:43.740 --> 06:50.620 Please note that the FDA does not endorse one type of real-world data over another. 06:51.180 --> 06:58.300 They're all the same. They're all great. Assess the reliability and relevance of the source 06:58.300 --> 07:04.780 and the specific elements to determine whether real-world data sources and the proposed analysis 07:04.780 --> 07:11.340 can generate evidence that is sufficiently robust to be used for a given regulatory purpose. 07:12.300 --> 07:21.420 The primary factors FDA considers are assessing the reliability of data include data approval 07:22.380 --> 07:31.740 that is how the data were collected and data assurance that is whether the people and processes 07:31.740 --> 07:40.700 in place doing data collection and analysis provide adequate assurance that errors are minimized 07:40.700 --> 07:44.060 and that the data quality and integrity are sufficient. 07:48.060 --> 07:53.340 Real-world evidence might be used in support of regulatory decision-making in several situations 07:53.900 --> 08:02.140 as listed here. For more detail in all of the 08:02.940 --> 08:07.900 sections, I refer to section six of the guidance. 08:18.140 --> 08:23.900 So before I end, I have two slides where I want to address a couple of questions, 08:23.900 --> 08:30.940 common questions from sponsors which plan to transition an EUA IBD product to a full market 08:30.940 --> 08:38.620 application. The first question is, can I use the analytical and clinical data obtained for an 08:38.620 --> 08:46.060 EUA authorization? The answer is yes, if new modification to the device has been made since 08:46.060 --> 08:52.940 the authorization. However, if modifications have been made, then the risk assessment of the 08:52.940 --> 08:59.020 modification will be required to determine to which extent the changes to the device would 08:59.100 --> 09:05.980 influence its performance. For clinical data, it's important to assure that the comparator 09:05.980 --> 09:11.420 method used to determine the truth of the specimen is still viewed as an acceptable 09:11.420 --> 09:20.380 preference method. And the second question, can I use generated the data outside of the US 09:20.380 --> 09:28.220 for my FDA submission? The answer here is yes as well provided that the test procedure and 09:28.220 --> 09:35.100 performance, the test procedure was performed according to the package insert with no deviations. 09:36.060 --> 09:42.060 We encourage sponsors to contact early, as early in the development for questions 09:42.060 --> 09:46.700 concerning the use of EUA data to support marketing submissions. 09:48.620 --> 09:55.900 The last question, can real data be used to help support the advancement of EUIBD products 09:55.980 --> 10:00.860 through full marketing status? As stated in the guidance, I just reviewed 10:01.580 --> 10:07.180 under the right conditions, yes. Data derived from real-world sources 10:07.180 --> 10:13.260 that potentially be used to support regulatory decisions. And under the right conditions, 10:13.260 --> 10:19.500 real-world data and associated real-world evidence, they constitute valid scientific evidence 10:19.500 --> 10:25.340 depending on the characteristics of the data. As I mentioned earlier several times, 10:25.340 --> 10:32.380 we encourage sponsors to contact us early in the development for questions concerning data to support. 10:32.380 --> 10:42.380 So data derived from real-world sources becomes validation. That's what we're doing here now. 10:42.380 --> 10:48.700 We're allowing these EUA devices to be rolled out and then for them to collect their own data, 10:48.700 --> 10:57.340 report their own results, call it real-world data and be a source of validation for a market 10:57.340 --> 11:04.060 approval submission. And it's as simple as that. He's telling you exactly how it's done. Yes, 11:04.060 --> 11:09.660 it can happen. This is the way it's done. This is where the reliability has to be feigned. 11:09.660 --> 11:15.420 This is where these are the benchmarks that you need to meet. That's what he's saying. 11:15.420 --> 11:16.460 It's extraordinary. 11:18.460 --> 11:22.220 Marketing market applications. This is my last material slide. 11:24.140 --> 11:30.940 I want to thank my division, the whole staff of my division of the Division of Microbiology 11:30.940 --> 11:38.220 Devices. Everybody is one way or the other involved in EUAs. And I would like to especially 11:39.100 --> 11:45.340 acknowledge the individuals listed here because they have performed the heavy lifting in most of 11:45.340 --> 11:55.340 the EUAs that we have seen. All those thanks to OC and OCC for their continuous help as well as 11:55.340 --> 12:01.020 to our colleagues from SIBO who have helped us with standards which you will develop. 12:01.980 --> 12:09.900 These are the individuals who make EUA happen. They have stand up to any call of an emergency 12:09.900 --> 12:16.940 and they have worked tirelessly over weekends to make these devices available to the public as 12:16.940 --> 12:19.100 fast as possible. Thank you. 12:19.100 --> 12:20.860 Tirelessly over the weekend. 12:20.860 --> 12:33.020 And so that guy was essentially what he said was that he is the head of all the EUA because 12:33.020 --> 12:40.780 this whole division of microbiology devices is EUAs, this whole department. So the division 12:40.780 --> 12:46.860 of microbiology devices, isn't that an interesting division to be the head of for 20 years? 12:47.500 --> 12:53.740 To get three houses for heading to not lose your accent? 12:53.740 --> 12:56.540 Really wanted to thank everybody. It's good that we've got incredibly good time 12:56.540 --> 13:00.220 for making out your critical positions, isn't it? 13:00.220 --> 13:04.860 As a note to the Office of the Chief Scientist for actually being able to help facilitate a lot 13:04.860 --> 13:11.420 of this work in the medical device innovation consortium where we could actually get a conference 13:11.500 --> 13:18.460 together in very short time. So Frank Whitehold in particular has been in short time. 13:18.460 --> 13:22.380 The ladies that started the conference said that they've been organizing this for months. 13:23.820 --> 13:26.700 What is he talking about? Is that a short time to him? 13:26.700 --> 13:32.300 Incredibly important in actually helping do a lot of the background work that is 13:32.300 --> 13:36.940 helping facilitate hopefully the future for the collection of rural evidence. 13:36.940 --> 13:43.500 And so to go on with Dr. Shur and Dr. Stenzel we're actually talking about 13:46.060 --> 13:50.860 just let's drill down just a little bit more in the rural evidence and fundamentally 13:51.820 --> 13:54.460 while he wants to drill down the real world evidence. 13:54.460 --> 13:58.300 There was a 21st Century Cures initiative and we had the FDA reauthorization act 14:00.540 --> 14:06.620 which led to Meduva for commitments actually to help get pre-imposed market information 14:07.180 --> 14:10.540 to support regulatory decisions across the breadth of which. 14:10.540 --> 14:12.460 That was a mention of something very important. 14:12.460 --> 14:13.740 The 21st Century Cures initiative. 14:13.740 --> 14:23.900 21st Century which led to Meduva for commitments actually to help get pre-imposed market information 14:24.460 --> 14:28.060 to support regulatory decisions across the breadth of which it could pop. 14:28.060 --> 14:36.860 A huge amount of real important legislation that underlies the possibility of pandemics. 14:37.420 --> 14:43.820 Being executed in the way that they were executed this time is found in the 21st Century Cures 14:43.820 --> 14:49.980 Act and initiative. And I strongly recommend that everybody look into that if you've never 14:49.980 --> 14:57.020 heard of it before. I am a little bit less informed about this one that I am about prep 14:57.020 --> 15:05.580 and about the National Vaccines Act but this one is essential and it's a part of this stepwise 15:05.580 --> 15:12.300 move toward the prep act. And so I need to read into this as well but it's interesting 15:12.300 --> 15:14.540 that he mentions that one as being pivotal. 15:14.540 --> 15:19.420 Completely used. And underneath that the medical device innovation consortium has the 15:19.420 --> 15:27.980 national evaluations system for health technology to help develop a space where real 15:27.980 --> 15:33.660 evidence could actually fundamentally be used. Now in the Center for Devices and Real Logic Health 15:33.660 --> 15:38.860 we actually have a strategic priority to do this and part of the strategic priority was 15:38.860 --> 15:45.260 this guidance that that Uva just talked about which is a cross-center harmonized effort. 15:45.900 --> 15:50.860 Now again you're probably going to see this many times throughout the day but 15:51.580 --> 15:56.860 that context of collecting information from a real clean health care setting. 15:57.420 --> 16:02.620 Obviously that information if it's going to be collected it's going to have to be analyzed to 16:02.620 --> 16:09.020 be able to be used in the context of valid scientific evidence. Now what are we talking about? 16:09.020 --> 16:14.540 In the traditional setting you know obviously many of you are familiar with the fact that 16:14.540 --> 16:19.660 studies are designed and they're conducted and analyzed. And then when those devices go out to 16:19.660 --> 16:26.940 market I please note the context here that an ID is probably not necessary in every single 16:26.940 --> 16:31.820 situation. In some cases it might be and I would refer to the Rural Evidence Guidance 16:31.820 --> 16:39.020 to actually provide the context for that but when those devices actually get to market 16:39.900 --> 16:45.180 or get to actual use in a health care setting they begin to help generate data. 16:45.900 --> 16:51.100 Then that data when it's generated is done in a natural health care setting and then the question 16:51.100 --> 16:58.860 is how can we collect and analyze that information so it can actually be useful. And so this is an 16:58.860 --> 17:03.740 unprecedented shift in the way we think about medical records and medical data and they are 17:03.740 --> 17:09.660 shifting it at a very opportune time right before the pandemic starts when we're going to grant 200 17:09.660 --> 17:16.540 plus EUAs for diagnostics that could actually be the data collection that could be reflected back 17:16.540 --> 17:24.300 on the nationwide electronic medical records etc. They are talking about a national 17:25.100 --> 17:38.540 security priority here right this is a national security priority and so all of this talk about 17:38.540 --> 17:45.420 what to do with the data and how to collect it has built into it these national security priorities 17:45.420 --> 17:51.340 which may actually lead to them doing things that they wouldn't otherwise do collecting data that 17:51.340 --> 17:58.300 they wouldn't otherwise do and interfacing with electronic medical records in a way that they 17:58.300 --> 18:09.580 wouldn't otherwise do in order to facilitate a national security priority of moving more EUA products 18:09.580 --> 18:22.060 to full market approval I can't write worth a damn when I'm actually talking while I write and 18:22.060 --> 18:29.100 trying to write what I'm saying because then I try to write too fast so what does this say moving 18:29.660 --> 18:37.420 more EUA products to full market approval I should write that without so such scribble scratch here 18:37.500 --> 18:43.100 but that's the national security priority that has been ascribed to the entire seminar 18:45.020 --> 18:49.820 I'm so glad I got to close this out with a little bit of a of a closer here because it's really 18:49.820 --> 18:57.580 this is really summarizing the last three the last three so well as we looked at this seminar from 18:57.580 --> 19:04.380 February 3rd 2020 what we are seeing is that the national security priority is not the safe and 19:04.380 --> 19:09.660 effective products that are rolled out but it is getting more EUA products to successfully get 19:09.660 --> 19:16.380 to full market approval using this shift from having to go through a pre-market submission system 19:16.380 --> 19:23.500 to being able to use real world evidence gathered during the EUA stage to get through the approval 19:23.500 --> 19:27.100 process without having to go through all this pre-market submission stuff 19:28.060 --> 19:37.340 replacing what was required in a pre-market submission as outlined by Louvay sheriff that includes things like 19:40.940 --> 19:47.660 that includes quality control that includes precision that and now can instead be substituted 19:47.660 --> 19:54.620 within silico evaluation and no full validation is required and and that means that all of these 19:54.700 --> 20:00.300 things can in theory get through with real world evidence that has been misconstrued as validating 20:00.300 --> 20:10.380 their effectiveness and that is a very dangerous place to be had February 3rd 2020 February 3rd 20:11.340 --> 20:17.100 it hasn't even started yet and we're already throwing all regulatory systems out of the out of the 20:17.740 --> 20:25.580 out of the window and having a german national with a thick accent explained to us how we can 20:25.580 --> 20:32.620 circumvent the traditional methods of pre-market approval before full market approval of the FDA 20:32.620 --> 20:39.020 by getting an EUA and doing everything with real world data that can even include things as mundane 20:39.580 --> 20:48.140 mobile device data never mind data from other EUA products right which could also be used to 20:48.140 --> 20:53.420 evaluate whether or not the virus was there and so then one EUA product is validating the 20:53.420 --> 21:01.180 effectiveness of another EUA product don't you see it holy cow it's amazing in that space 21:02.140 --> 21:08.620 fundamentally we need data quality data quality is a very important key yeah it's all processed 21:08.620 --> 21:14.300 data quality understand what the information is inside of a health care system exactly how 21:14.300 --> 21:18.620 are you going to be able to use it now this question is the common question 21:20.140 --> 21:26.220 that really drives the next statement of what is valid scientific it's fundamentally so per 21:26.220 --> 21:33.180 our regulations you can submit anything you want to but fundamentally we can only rely on 21:33.180 --> 21:38.300 valid scientific evidence and to be a little more clear about what valid scientific evidence could 21:38.300 --> 21:44.940 be it really is a very broad breadth and range um well controlled investigation parcel controlled 21:44.940 --> 21:50.300 studies objective trials and even reports of significant human experience if it can actually 21:50.300 --> 21:57.100 be determined that you know by qualified experts that there's reasonable assurance 21:57.100 --> 22:04.860 of safety and effectiveness that are real world personal experience can also be used to evaluate 22:04.860 --> 22:11.260 the effectiveness of an FDA device here he just said those words you want to hear him say him again 22:11.740 --> 22:14.620 I'll roll it back half a second now information 22:17.580 --> 22:22.460 objective trials and even reports of significant human experience if it can actually be determined 22:23.260 --> 22:28.700 that you know by qualified experts that's impressive there's reasonable assurance 22:28.700 --> 22:35.260 to say from the fact that information that's impressive that's impressive and has been used 22:35.260 --> 22:41.420 support regulatory decisions it doesn't always follow the traditional space but certainly 22:42.300 --> 22:50.300 it's noted that things that are weird really can't be used as valid scientific evidence is it's not 22:50.300 --> 22:56.460 logical a rationality section kind of be taken into place so what is not regarded as valid 22:56.460 --> 23:03.100 scientific evidence is your isolated case reports are random experiences um if you don't have enough 23:03.100 --> 23:08.620 detail around it how do you actually use utilize that information this is where the key comes in 23:09.180 --> 23:13.740 so all we care about the end of the day is information that's fit for purpose and the appropriate 23:14.380 --> 23:20.540 yes he did of a particular setting so we're talking he did he said weird things we don't use 23:20.540 --> 23:25.420 weird things weird things are not generally scientific but you know it's a individual evaluation 23:25.420 --> 23:31.180 basis talking about information that's relevant and reliable we have to be able to make a determination 23:31.180 --> 23:35.980 fundamentally that the benefits outweigh the risks and that we can actually utilize that 23:35.980 --> 23:43.500 information and throwing in a little extra complexity into that setting of course is that we try to 23:43.500 --> 23:48.700 make sure that patients information is properly protected so we have harmonization for that 23:48.700 --> 23:56.300 information it does become a little more understandable at how you can actually navigate patient 23:56.300 --> 24:01.980 protection information and get high quality information out so in the rural evidence space 24:03.980 --> 24:09.260 now he's using very big words to describe how they are going to try to protect people's personal 24:09.260 --> 24:15.820 data while using it to evaluate EUA devices I don't think you can hear it any other way he 24:15.820 --> 24:22.300 used the phrase here at the bottom information harmonization do you know what that is that's got 24:22.300 --> 24:29.180 to be the the interface between an electronic medical record database and the database of a 24:29.180 --> 24:37.820 pharmaceutical company the database of a social media company interfacing with the data from a 24:38.940 --> 24:44.380 electronic medical medical record database would be information harmonization and talking about 24:44.380 --> 24:50.300 how to anonymize make all anonymous the data or to protect people's personal data 24:50.300 --> 24:55.900 is precisely what you would talk about if you intended to use a national security priority 24:55.900 --> 25:02.780 to allow people to create information harmonization when that would no way shape or form be allowed 25:03.420 --> 25:06.860 under the normal laws governing medical data and its use 25:09.900 --> 25:15.180 that's why he has to use these big words and talk with such obfuscating sentences because 25:15.180 --> 25:22.860 he doesn't tell you want everyone to understand it does become a little more understandable 25:22.860 --> 25:27.500 at how you can actually navigate patient protection information and get high quality 25:27.500 --> 25:36.780 information out so in the rural evidence space the HIPAA privacy role is how we operate for 25:36.780 --> 25:42.780 helping protect that information and the understanding that not everything in the research space is 25:42.780 --> 25:49.100 covered under under HIPAA that the access and use for the common role helps provide a little 25:49.100 --> 25:57.020 additional context there but that being said information in the rural setting has been used 25:57.020 --> 26:03.420 in many different spaces there for indication expansion for new indications for condition of 26:03.420 --> 26:07.900 approval in both a pre-market and post-market setting and all these slides will be available 26:08.300 --> 26:14.620 online if you want to do a deep dive but there has certainly been information collected from 26:14.620 --> 26:19.820 multiple different venues and the point is please be creative and don't limit yourself 26:19.820 --> 26:24.140 to that information. The perfect example which I think may have a degree of applicability 26:24.700 --> 26:33.180 in this setting in particular is the note of an ability to actually utilize a publicly maintained 26:33.180 --> 26:38.620 database when we actually partner together what was able to happen here in the next 26:38.620 --> 26:42.780 chance sequencey space and I think that something that could be replicated in an EUA space next 26:42.780 --> 26:50.620 gen sequencing appropriately set up is in lieu of full traditional studies what we're able to use 26:51.260 --> 27:00.700 is information directly harvested from a publicly retained a publicly maintained database because 27:00.780 --> 27:09.020 there was collaboration that happened up front between the sponsors between the database folders 27:09.660 --> 27:15.180 and between FDA and when we actually partner together to get interoperability for that data 27:15.740 --> 27:20.860 and establish appropriate quality checks which are achievable it was achievable in this case 27:20.860 --> 27:25.740 and it'll be achievable in the future we can actually work together if you have questions 27:25.740 --> 27:31.100 about real-world evidence there is actually an email address if you don't want to contact 27:31.100 --> 27:36.700 the divisions directly you can you can email c3h clinical evidence at fda.h just.gov and if you 27:36.700 --> 27:40.860 want to learn more about some of the public private partnerships you can contact c3h clinical 27:40.860 --> 27:47.580 evidence at fda.h just.gov or if you want to learn more about shield in the diagnostic space you can 27:47.660 --> 28:01.820 contact me thank you so thank you to all of the fda colleagues for sharing the fda perspective 28:01.820 --> 28:07.820 today I think it sets a wonderful foundation for our discussions today and I look forward to 28:07.820 --> 28:12.780 your engagement throughout the day as well we're going to take a break now and I'm going to make 28:12.780 --> 28:19.020 a deal with you you guys silence your phones I'm hearing some phones and I promise we'll work 28:19.020 --> 28:24.380 on getting those technology smoothing up here how's that for a deal wow so they're done that 28:24.380 --> 28:30.780 was the end of that one and that's fine I knew it was not the much left because I didn't want to 28:30.780 --> 28:37.740 leave it till after practice and then have to do that so we are still here ladies and gentlemen 28:37.740 --> 28:40.860 at the same place where we have been for a very long time 28:43.340 --> 28:45.660 oh I didn't mean to do that I apologize 28:48.460 --> 28:52.380 you like that thing though I don't think it's that bad it actually looks pretty good that's also 28:52.380 --> 28:58.220 render forest you know render forest is kind of fun so that was the last part of the market seminar 28:58.220 --> 29:03.660 we won't do that one anymore I've taken my notes I've got my stuff I've got a lot more work to do 29:03.660 --> 29:09.500 on Uve Sheriffs patents and some of the country companies that he worked for and we're going to 29:09.500 --> 29:14.700 look at I'm going to look at some of his publications and try to decide if it's possible that maybe he 29:14.700 --> 29:22.140 was doing more than just giving out EUAs maybe he was involved in the Human Genome Project or 29:22.140 --> 29:26.860 in collaboration with companies that were involved in the Human Genome Project and 29:26.860 --> 29:31.420 that might give us a clue to why he was in charge of giving away diagnostic EUAs 29:32.060 --> 29:37.820 and and why it would be that EUAs would be given away by single people or by some weird 29:40.540 --> 29:47.020 division called microbiome microbiological devices which is a very bizarre thing 29:47.900 --> 29:52.940 so thanks for coming back for the last half hour if you missed it live thanks for coming back and 29:52.940 --> 29:58.220 checking it out I will try to be on later this evening and later this evening I've got at least 29:58.940 --> 30:06.380 a list of 20 or so things that I could cover and so we'll just see which of these pending 30:07.020 --> 30:11.740 sort of study halls that is necessary to do that I'll do at eight o'clock and I'll see you then 30:11.740 --> 30:19.980 thanks very much for coming and we'll be back soon