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Re: sharinky post# 196168

Wednesday, 06/12/2019 1:26:32 PM

Wednesday, June 12, 2019 1:26:32 PM

Post# of 425915
Of course there's a deadline - FDA can't spring an AC on somebody a month before the PDUFA. IIRC, people backtracked from the PDUFA of 9/28 using guidelines for when certain events must occur, AC is 6 wks from PDUFA, FDA must inform the company of an AC 55 business days before that date, tallied up the deadline passed on either 6/10 or 6/11.

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