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clock Created with Sketch. 25/11/22
20:22
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Originally posted by hottod:
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So what you're effectively saying is that if there's no announcement by March 1 everyone should sell. The PDUFA is a performance goal rather than a guarantee. That said, the FDA does a pretty good job of meeting its performance goals. Last year, 100% of priority review designated NMEs (i.e. novel drugs) were acted on by their assigned PDUFA dates.not aware that the FDA can sometimes approve well before the PDUFA date. Btw, I’d be interested for people here to let me know if that thinking was correct.
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Your post was very clear and informative as ever. @Saus provided are helpful but gives only partial insights about stats concerning early approvals.
Last edited by
Clppr :
25/11/22
(20min delay)