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Re: sharinky post# 213389

Tuesday, 09/10/2019 3:38:40 PM

Tuesday, September 10, 2019 3:38:40 PM

Post# of 426330
FDA doesn't need to formally move back or "delay" the PDUFA - they can just leave it on 9/28, have the AC on 11/14, then approve the new label whenever they feel like it - PDUFA is a goal date, not a hard deadline. What they're delaying is approval of the label change.

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