@dachopper great post , I don't know how i missed it till now... I have been searching for evidence of recent early FDA approvals... and here it is on HC
Thank you great Sluething mate...
from dachopper post on the 9th March...
GVHD approval decision 2 Apr 23 to 2 Aug 23 ( 2 - 6 months for fast track*)
*Zanubrutinib - a drug for treating mantle cell lymphoma, was approved over 3 months ahead of its PDUFA date, late in 2019, along with at least onother 4 drugs, all approved earlier than the PDUFA date given by the FDA.
Crizanlizumab-tmca approved 2 months before PDUFA in 2020.
Voxelotor accelerated approval three months before PDUFA.
Givosiran 2.5 months before it's PDUFA date.
It is not a given that the yes / no will occur on the actual PDUFA date.
Source : https://endpts.com/fda-approves-5-new-costly-drugs-well-ahead-of-pdufa-dates/
very pleasing to see above...
2023 The Final Countdown, page-64
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