AGRX - Agile Therapeutics: Twirla AdCom Provides Investors A Bridge To PDUFA
Back in May, Agile Therapeutics (AGRX), revealed that they resubmitted their NDA for its primary product candidate, Twirla, a low-dose combination hormonal contraceptive patch. Shortly after, Agile announced that the FDA accepted Twirla's NDA resubmission with the PDUFA date set for November 16th. Much to my dismay, the FDA did not schedule an advisory committee "AdCom" to appraise Twirla. In my previous article, I discussed my anxieties about Twirla not having an AdCom prior to PDUFA due to the products previous CRLs and the potential for a strong sell-off going into the