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Re: midastouch017 post# 3507

Wednesday, 04/28/2021 3:01:36 AM

Wednesday, April 28, 2021 3:01:36 AM

Post# of 3999
And indeed from an outsider's perspective, no they are not that busy. At least not with regards PDUFAs

https://www.biopharmcatalyst.com/calendars/pdufa-calendar

Looking at the FDA PDUFA calendar we can see that they had no PDUFA in January, 1 PDUFA in Feb that they missed, no PDUFA in March.

This month April, they had 5 PDUFA of which 3 already missed, and the PLX PDUFA which was there yesterday, now has disappeared? However we know that GSK Jemperli was initially planned for a January PDUFA was just recently approved, and in the PDUFA calendar there is no GSK PDUFA mentioned going back to at least July 2020. So GSK's PDUFA which was also Priority Review has also disappeared from the PDUFA calendar.

Very odd FDA behaviour.

But it would seem that in Jan, Feb, March, the FDA didn't have much to do on PDUFAs anyway, unless they were removed too?
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