(Total Views: 869)
Posted On: 09/01/2020 1:16:52 AM
Post# of 154776
This statement is FALSE without clarification
"Either way, CytoDyn must resubmit the BLA and the clock is completely reset"
The clock is absolutely not reset toward the PDUFA date because they have a rolling review. Now if you mean reset with respect to them responding for a PDUFA date I will give you that becaue the PDUFA date could be December because they have had so much time for review.
Now wouldnt this be a HUGE question to ask on the conference call? I hope someone reads this and asks.
"Either way, CytoDyn must resubmit the BLA and the clock is completely reset"
The clock is absolutely not reset toward the PDUFA date because they have a rolling review. Now if you mean reset with respect to them responding for a PDUFA date I will give you that becaue the PDUFA date could be December because they have had so much time for review.
Now wouldnt this be a HUGE question to ask on the conference call? I hope someone reads this and asks.
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