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Foro de Bolsa > Farmas USA

News: Priority Review "within 60 days of receipt", Stockvadar-quotes FDA

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Re: Farmas USA

Pervius

News: Priority Review "within 60 days of receipt", Stockvadar-quotes FDA

Priority Review is not Fast Track, but if Priority Review is granted, the PDUFA date would be 6 vs 10 months from original receipt of sNDA, September-October.

Note: the FDA could respond at any time right now - "within" key word. If we go beyond 60 days, it's normal 10 month timeline.

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Pervius
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