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Re: cowtown jay post# 18504

Thursday, 09/24/2020 5:22:59 PM

Thursday, September 24, 2020 5:22:59 PM

Post# of 42433
The data cannot be used to request an EUA, or an approval until the trial is complete, data compiled, locked and unblinded.

If enrollment completes 9/30, the trial will be completed 60 days after due to the Secondary endpointss that are 60 days.

After the 60 days, the unblinding process will take a week or two, and then the analysis another couple of weeks.

So, I see an EUA request occurring end of December/beginning of January. currently FDA is taking about 30 days to review EUA requests.