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Re: pqr post# 389824

Tuesday, 12/06/2022 1:46:59 PM

Tuesday, December 06, 2022 1:46:59 PM

Post# of 461390
First they will file an NDA not a BLA. Second that depends on what the results of the meeting with the FDA are. 3 months would exceptionally fast. 6 months is in the realm possibilities. After an second P3 trial is the FDA asks for one.

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