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Anshu2

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Anshu2

Re: None

Friday, 05/12/2023 11:49:39 PM

Friday, May 12, 2023 11:49:39 PM

Post# of 462893
So much silly discussion on P3 vs P4 etc.

This is how AA works per FDA.

(Bunch of trials, irrespective of names) ——> AA ——> Confirmatory trial (name P3 or P4 doesn’t matter) ——> Full Approval.

Yes, during the AA application process, FDA likes the confirmatory trial to be already designed and running.
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