Twirla is ready for approval on Nov 16th

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.

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I would say mid-January at the earliest for Twirla approval.

I don't know...look at the price action on the stock the last three days. Started the week around 2.05 and now at 2.46. Maybe someone knows something about approval soon.

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You think we wait until February? If not, December or January?

I would say mid-January at the earliest for Twirla approval.

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The FDA came back to Agile in Mid-November and said they were extending the PDUFA date for Twirla to no later than February 16th, 2020. Approval is still expected.

You think we wait until February? If not, December or January?

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The FDA came back to Agile in Mid-November and said they were extending the PDUFA date for Twirla to no later than February 16th, 2020. Approval is still expected.

What's the chance Twirla doesn't get approved or even has a black box warning?

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The FDA came back to Agile in Mid-November and said they were extending the PDUFA date for Twirla to no later than February 16th, 2020. Approval is still expected.

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From the briefing docs. It sounds like there were some more favorable pages in the briefing docs but this was from pages 11,12. What I read wasn't all that favorable?


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From the briefing docs. It sounds like there were some more favorable pages in the briefing docs but this was from pages 11,12. What I read wasn't all that favorable?


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Not until they get approval.

Oppenheimer is confident for Twirla approval

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Does anyone know if they have started the hiring process for sales reps?

Not until they get approval.

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Does anyone know if they have started the hiring process for sales reps?

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