Agile’s Twirla Heads To Advisory Committee: No Mystery Why
Contraceptive patch has had rocky regulatory path with US FDA. To Agile’s credit, the company pulls no punches in its shareholder filings in explaining the situation.
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Agile's transdermal contraceptive will go before the Bone, Reproductive and Urologic Drugs Advisory Committee as it nears the end of its third review cycle, although the agency appears ready to issue another complete response letter before it even hears from the panel.
Success rate for sponsors pursuing appeals of FDA rejections is much higher than reported by agency, a leading US regulatory law firm argues. Agile Therapeutics’ “loss” of an appeal is a good example of how sponsors can still benefit even if their formal request is denied.