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Alias Born 02/06/2021

Re: None

Wednesday, 06/16/2021 2:34:30 PM

Wednesday, June 16, 2021 2:34:30 PM

Post# of 349
Reminder that PDUFA extension was due to FDA requesting more info regarding labeling issues, trial conduct, CMC, safety

Also important to note that FDA issued a PDUFA extension not a CRL so that's good news too