Tuesday Jan 12th data s/c unblinded. We expect an
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Posted On: 01/10/2021 2:22:04 AM
Re: onestepahead #72057
Tuesday Jan 12th data s/c unblinded. We expect an acceptable p value and Stat Significance. Quick turn around for an EUA? What does that mean?
Is an EUA possible at the earliest by Jan 18th Monday?
Or does "quick turn around mean quickly after Top Line Report is prepared by Cytodyn and submitted with the application to the FDA for an EUA?
All s/c trial sites must organize data and then send it to Cytodyn. Then Cytodyn must organize a massive amount of data and prepare the Top Line Report, might that require several weeks at least?
Might an EUA be issued by Jan 18th, before the FDA receives the Top Line Report, and then full FDA approval, after FDA gets the Top Line Report?
Is an EUA possible at the earliest by Jan 18th Monday?
Or does "quick turn around mean quickly after Top Line Report is prepared by Cytodyn and submitted with the application to the FDA for an EUA?
All s/c trial sites must organize data and then send it to Cytodyn. Then Cytodyn must organize a massive amount of data and prepare the Top Line Report, might that require several weeks at least?
Might an EUA be issued by Jan 18th, before the FDA receives the Top Line Report, and then full FDA approval, after FDA gets the Top Line Report?
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