Great summary right here...Twirla is ready to get approved!!
We’ll Folks, the CEO is quite clear, “Twirla is ready for approval, Nov 16th.”
Let me break it down further for y’all:
1. Corium International is primed and ready to go - FDA audits frequently and has cleared the factory for manufacturing of the transdermal patch for Twirla.
2. The recent offering lined up all financing needed for a successful launch into the first Q of next year. $22 Million in CASH!
3. NEW merger and acquisitions CFO hired and is prepared to take Agile to the next level post approval - Form 4’s to prove it!
4. Odds are better —3rd time around
5. In Vivo Adhesion is a NON issue now that the comparative wear study has eliminated any concern regarding adhesion of the patch.
6. Recent studies and papers published by the FDA agree with Agile’s Pearl Index BMI standard with regard to efficacy —Agile’s is the new Gold Standard to be adopted at some point as our society becomes more obese overtime - Diet
7. Political climate relative to ******** and safety.
