(Total Views: 644)
Posted On: 07/15/2020 10:35:19 AM
Post# of 154119
Ok, I think I understand your point.
I believe your assumption is that the FDA demands both a larger P3 M/M and a 50% (195) interim look at the P3 S/C -- and that easily pushes potential COVID approval out by 2-3 months.
However, if the FDA drags their feet (or is just plain overloaded) in terms of scheduling and subsequently attending the Type A Meeting, and if CytoDyn needs even more time to process and format the new data set based on the outcome of the meeting -- we might be looking at the same timing issues. Namely, that the FDA will possibly only receive the new data (with no time to ingest or process) at around the same time that we might be asking for approval again.
I realize my rants smack of pessimism. I view this new last minute demand for an integrated assessment of the Mono data set as being a blatant overreach, that includes data that they do not need -- unless they intend on approving Mono, which seems impossible. So, based on historic bad behavior towards CytoDyn, I simply don't trust them.
I believe your assumption is that the FDA demands both a larger P3 M/M and a 50% (195) interim look at the P3 S/C -- and that easily pushes potential COVID approval out by 2-3 months.
However, if the FDA drags their feet (or is just plain overloaded) in terms of scheduling and subsequently attending the Type A Meeting, and if CytoDyn needs even more time to process and format the new data set based on the outcome of the meeting -- we might be looking at the same timing issues. Namely, that the FDA will possibly only receive the new data (with no time to ingest or process) at around the same time that we might be asking for approval again.
I realize my rants smack of pessimism. I view this new last minute demand for an integrated assessment of the Mono data set as being a blatant overreach, that includes data that they do not need -- unless they intend on approving Mono, which seems impossible. So, based on historic bad behavior towards CytoDyn, I simply don't trust them.
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