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exwannabe

06/30/24 10:12 AM

#702585 RE: Reefrad #702578

Which means that the number 150 means nothing other than “accelerated review”, subject to unquantifiable delays.


Per LP that have not yet even received confirmation of being accepted for 150 day review program.

BTW, had they gone to the FDA instead the PDUFA date (assuming priority review) would have been last week.
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FeMike

06/30/24 11:12 AM

#702606 RE: Reefrad #702578

Which means that the number 150 means nothing other than “accelerated review”, subject to unquantifiable delays.



I mean…yeh.

Have you seen MHRA’s performance data on MAA turnaround time? It’s abysmal. They never hit their targets and the median is like 100 days beyond target.