This has been nagging me: We know that the FDA
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Posted On: 07/19/2020 2:20:03 AM
This has been nagging me:
We know that the FDA did not grant a PDUFA date for the Combo HIV indication because they wanted an integrated analysis of the 700mg dose from the CD03 Mono Trial.
How can we expect the FDA to grant approval or EUA for COVID if the Type A Meeting has not taken place, and if CytoDyn has not yet provided the FDA with that CD03 integrated analysis?
We know that the FDA did not grant a PDUFA date for the Combo HIV indication because they wanted an integrated analysis of the 700mg dose from the CD03 Mono Trial.
How can we expect the FDA to grant approval or EUA for COVID if the Type A Meeting has not taken place, and if CytoDyn has not yet provided the FDA with that CD03 integrated analysis?
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