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Wednesday, April 29, 2020 11:58:59 PM
(Ran out of whiskey!)
So, I've spent the better part of the past 6 hours re-analyzing the PRs from 3/3 to 4/27 and building a timeline of references and tracking the development of the test kit and submission to FDA for EUA. I will try to find a way to submit what I have put together for your consideration; however, I will say that if you know the new FDA guidance for EUA submissions for diagnostics, Berman is pretty much right on track. Two things became very apparent, one of which I plan to email him about tomorrow: 1) he needs to take a course in Organizational Writing or at least let someone read the PRs before he submits them, and 2) he clearly knows what he is doing and is doing it correctly - regarding the submission (whether or not the FDA will grant the EUA authorization is THE question).
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