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kund

12/06/22 10:58 AM

#389829 RE: pqr #389824

25th Jan 2065

Steady_T

12/06/22 1:46 PM

#389939 RE: pqr #389824

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.