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Re: cowtown jay post# 33909

Wednesday, 10/13/2021 4:51:41 PM

Wednesday, October 13, 2021 4:51:41 PM

Post# of 42748

That portion of the NIH trial is complete. Durrant actually said that we were going to submit additional data to the FDA from both the LIVE-AIR trial, as well as the ACTIV-5 trial.


The ACTIV-5 trial is ongoing. It isn't normal to unblind data while a trial is in progress. Durrant said they would first submit non-ACTIV-5 data to try for the EUA. Then they would submit ACTIV-5 trial data when it completed. The one thing that does jive with the ACTIV-5 trial is that they are submitting data from 200 patients. There might have been an interim analysis at 200 patients since there was an interim analysis at 100 patients and the original trial was designed for 200 patients.