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Re: jcon777 post# 3531

Wednesday, 04/28/2021 10:59:37 PM

Wednesday, April 28, 2021 10:59:37 PM

Post# of 3999
Management is not in control of PDUFA date setting, the FDA is.

FDA is being very incompetent. I assume with the US Government Accountability Office being increasingly annoyed at the FDA for missing inspections, the FDA has decided to issue CRLs instead of delays, so as that way they will have given a 'decision' by the PDUFA date and will have met their KPI. Then they can just wait until they are ready, whenever that is, and then just give approval as they see fit.

Absolutely incredulous!

On the positive we know it is merely a covid travel delay and nothing more serious.
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