Therma Bright Inc V.THRM

FDA EUA Speed of Review in 1st 9 month…

[Watchman21]

More data on FDA & Volume of Covid tests they have reviewed and speed to approval.

It’s not a matter of months… more like days I believe, based on this data.

Since February 2020 through November 1, 2020 (9 months), the FDA used Emergency Use Authorization for over 285 diagnostic and serology Covid-19 tests.  That’s 9 months X 21 average work days per month is 189-190 work days at 285 tests.  That averages 1.5 per work day approved.  

I doubt we have that much more time to wait.  

Source:  https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/covid-19-test-development-and-review-faqs-testing-sars-cov-2Q: I submitted a pre-EUA or EUA request for a COVID-19 test. How long will the review take? (Updated 11/16/20)A: During this unprecedented public health emergency, the Agency has received an exceedingly high volume of EUA requests and is working as quickly as possible to review each request. There are hundreds of pre-EUA and EUA requests for COVID-19 tests under review and FDA continues to receive new submissions on a daily basis. To address this high volume of work, we have brought in additional scientific review staff to double the number of teams working on submissions; and we have implemented a triage program to prioritize submissions based on several factors. As a result of these efforts, by November 1, 2020, FDA had authorized over 285 diagnostic and serology tests, far exceeding the number of test EUAs issued during previous emergencies.

[TheeRook]

 That data is OLD . September 17, 2021 Testing updates:  As of today, 410 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 288 molecular tests and sample collection devices, 88 antibody and other immune response tests and 34 antigen tests. There are 62 molecular authorizations that can be used with home

[Watchman21]

@TheeRook.  Thanks for the updated data.  Great find.  And 440 within 18 month at an average of 20.5 workdays per month ... breaks down to 440 test variations / 369 workdays = averages 1.2 test variations per workday.  Still a rapid pace from March 2020 through Sept 2021 (18 months later)  Now why do I say 440 test variations versus 440 unique tests.  Re-check the

[InvrsContrarian]

This begs the question :what companies are better positioned to take advantage of your research. My best guess would be the ones that have more use cases already or about to be approved. Just further along the queue.

[Watchman21]

With the new Sept 23 FDA EUA  changes, looks like all the Antigen Tests will have to share actual test data against the Covid19 variants.  And change up the legalese on their packaging in 3 months.  If you read most of their websites, it's not clear they have "actually tested” for variants.  And also now either have to sticker or re-print some new

[Commoncents]

Now is the time, just a hunch but I see FDA coming this week! Good luck to us. 

[MarkAble]

No rush. The approval process will happen soon enough but I certainly don't see it happening this week. Covid and its variants will be with us for years, maybe a generation according to the WHO. I'm just interested in seeing what the pricing will be for the rapid test in the US. I read today that there are labs charging $340 for a single swab test in the US. Imagine how much cash flow THRM

[Smokey1958]

Your assessment would have been a reasonable one except for the fact that 1. Of the last 14 FDA EUA authorizations since June of this year almost half were being authorized for the first time. This suggests those with more use cases were in fact not at a particular advantage. 2. To your second point what is there to suggest that AcuVid is not about to be approved??? Your own rationale