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Re: tripmcneely post# 33846

Thursday, 11/24/2022 2:30:14 PM

Thursday, November 24, 2022 2:30:14 PM

Post# of 36581
trip..with the FDA they have to dot their I's and cross their T's. One mistake or miscommunication and they lose 6 months with the FDA. And they have to try and anticipate to read the FDA's mind. Example: a stock (ACER) had a PDUFA date of June 5, 2022 for final FDA approval of their drug. Then in May (1 month prior) the FDA requests to inspect their manufacturing facility. ACER was totally unprepared for the unannounced inspection, so they had to request a new PDFA date, which the FDA set the new date for January 2023..... even though ACER quickly had the site ready for inspect within 30 days. Murphy's Law!