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Friday, August 20, 2021 1:37:56 PM
RLFTF/NRXP have the advantage of already submitting a EUA application, which of course was rejected due to the small head count of patients, and so on. So the FDA has already taken a close look at HOW they package their EUA and they have provided them with valuable feedback/guidelines for the 2nd pass.
In addition, Dr JJ consumed a lot of time (3 months) analyzing and packaging the EUA submittal, so I surmise that he and his FDA savvy team have thought about every objection that the FDA could throw at them.
The FDA also is fully aware that NIH is conducting a formal trial of Aviptadil vs Remdes.., so the FDA will get egg on their face if they reject the EUA and then NIH later declares Aviptadil the WINNER. For this reason, I fear that the FDA may seriously delay their decision while they wait and wait for NIH to UNBLIND their data. I hope not. IMO they have enough data now to make a decision.
It's now the FDA's move in this game of chess, and they likely are a bit reluctant to make their move. Hopefully common sense will prevail.
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