AGRX - Agile Therapeutics: Debating My Position

Agile Therapeutics (AGRX), recently publicized that they resubmitted their NDA for its principal candidate, Twirla, a low-dose combined hormonal contraceptive patch. This recent resubmission was the end result of a CRL back in December 2017. The resubmitted NDA is comprised of the marks from a comparative wear study that was requested by FDA and supplementary info on Twirla’s manufacturing process with their partner Corium. The FDA has 30 days to communicate if the NDA was sufficient or not, and in most cases, the FDA makes the most of those 30 days. In the