Agile Therapeutics Inc (fka AGRX)

[mellow fellow]

“We don’t think this should even be required, as Twirla is a different product than Xulane/Ortho Evra, not a generic copy, so its benefit-risk profile—which we think is better—should stand on its own merits. Nevertheless, the minutes were consistent with our expectation for a straightforward two-week crossover study (one week on each patch) to show that Twirla adhesion is non-inferior (NI) to Xulane. The company has not disclosed the specific NI margin that the agency is requiring, but the planned sample size of only n=80 suggests to us that the FDA has given them some NI breathing room. We are confident in success based on Phase 3 adhesion data (more below). Agile already had the study teed up and ready to go, and has immediately initiated it with a dermatology-specialized CRO, TKL Research.”https://www.analystratings.com/articles/analysts-are-bullish-on-these-healthcare-stocks-agile-therapeutics-agrx-novabay-pharma-nby/