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AGRX: FDA Provides Path to NDA Resubmission for Twirla®…

10/10/2018
By David Bautz, PhD

NASDAQ:AGRX

READ THE FULL AGRX RESEARCH REPORT

On October 9, 2018, Agile Therapeutics, Inc. (NASDAQ:AGRX) announced that the company has concluded the formal dispute resolution with the U.S. Food and Drug Administration (FDA) regarding the complete response letter (CRL) issued for the new drug application (NDA) of Twirla®. While the FDA’s Office of New Drugs (OND) denied the company’s appeal, the agency did provide the company with a potential path to an NDA resubmission that would not include reformulating Twirla® or doing any type of bridging studies. Instead, OND suggested that Agile perform an adhesion comparison study between Twirla® and Xulane®, the generic version of the contraceptive patch Ortho Evra®. Since Xulane® is considered to have an acceptable adhesion profile by the FDA, demonstrating equivalent adhesive properties between Twirla® and Xulane® would be sufficient to show that Twirla® has adequate adhesion.

The company still needs to meet with the FDA’s Division of Bone, Reproductive and Urological Products (DBRUP) in order to come to an agreement about what the adhesion trial would look like. We estimate that the trial would take on the order of three to six months to complete and will likely initiate by the end of the first quarter of 2019, however these are just our best estimates at this point and the company has indicated that additional details regarding the adhesion trial will be forthcoming, along with details concerning the company’s cash runway. Regardless of the path forward, Agile is going to likely need two additional rounds of funding: one to take the company to an NDA resubmission and another for launching Twirla®, if approved.

If the adhesion properties of Twirla® are adequately addressed, the FDA will still need to review its safety and efficacy following resubmission of the NDA. This will likely include an Advisory Committee (“AdComm”) meeting, at which time such issues as the Pearl Index will be discussed.

Conclusion

Even though the FDA denied the company’s formal appeal, the details disclosed by the company regarding a potential path forward to an NDA resubmission are a clear positive and should be considered a “win”. We look forward to hearing additional details about the adhesion study and particularly the anticipated timelines to an NDA resubmission. Now that there is a much clearer path to market we have increased the probability of approval for Twirla® to 70%, however investors should be aware that additional financings will likely be forthcoming to fund the company through the NDA resubmission and potentially for commercialization. Based on these adjustments our valuation currently stands at $2.50.

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