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Re: MWM post# 32963

Monday, 09/06/2021 6:08:06 PM

Monday, September 06, 2021 6:08:06 PM

Post# of 42536

The fda has not requested nor have we been told that the trial size needs to be larger. You are speculating, if that’s what you think then you should come back in about three months.


Obviously, they want more otherwise an EUA would have already been granted. My guess is that they want to see the subgroup data reconfirmed in the ACTIV-5 trial. That is why they changed the patient population to coincide with where the trial subgroup had great data.