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Posted On: 05/20/2020 6:40:55 PM
Post# of 153815
Quote:We have a rolling review for Combo HIV which entitles us to a ruling within 6 months of the acceptance of the BLA. And the FDA has already been exposed to a number of those documents. Of course, if Gilead also has 8 of their officers on the FDA approval board -- it might take longer.
I may be wrong, but my understanding is that in the absence of accelerated approval (which we do not yet have for combo HIV), it could take up to 8 months for a ruling.
Quote:NP was referring to the 22-Solid Tumor Basket Trial.
NP was talking about 30 days just to get the next 10 patients injected.
Quote:A byproduct of a possible BTD decision for mTNBC is a Phase 4. I view this as not implausible.
I don’t expect any sort of decision on cancer from the FDA before September at the earliest.
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