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AGRX: Determining a Path Forward Following Receipt of Meeting Minutes

05/22/2018
By David Bautz, PhD

NASDAQ:AGRX

Business Update

Disclosure of Meeting Minutes

On May 18, 2018, Agile Therapeutics, Inc. (NASDAQ:AGRX) announced the content of the official meeting minutes following the Type A meeting with the FDA. According to the minutes, the FDA continues to have significant concerns regarding the adhesion properties of Twirla®, which the agency does not believe can be addressed by the currently available data. The FDA stated that in order to address the concerns the company would need to reformulate the transdermal patch and conduct a formal adhesion study with the new formulation. Following that, a bioequivalence study would need to be performed between the old formulation and new formulation, and if bioequivalence was not shown a new Phase 3 study would need to be conducted with the new formulation. If bioequivalence was shown, the agency anticipated an advisory committee meeting taking place to obtain input on whether the benefits outweigh the risks for Twirla®.

During the conference call, management stated that they disagreed with the agency’s conclusion and they believe that they have submitted all the data necessary to show that adhesion is not a major issue for Twirla®. In addition, the company has planned compliance and patient education programs that should satisfy the issues raised by the FDA. Management also stated that it likely does not make sense to reformulate or redesign the product, and that even if they were to do that a bioequivalence study for a patch is inherently difficult thus it would likely result in another Phase 3 trial being required.

While not official yet, the likely course of action for the company is going to be a formal dispute resolution with the FDA. FDA regulations for dispute resolution are governed by 21 CFR 10.75, which provides a mechanism whereby an applicant can obtain formal review of any FDA decision by the employee’s supervisor. Regulation 21 CFR 314.103 governs dispute resolution as they pertain to NDA filings, specifically scientific or medical disputes, which are first handled by the Division Director, then the Office Director, and finally with the Center Director if the matter is still unresolved. For each step of the process, the FDA has 30 days in which to conduct a meeting with the company once its requested, after which it has 30 days to issue a formal response.

We anticipate the company providing additional updates once a path forward is determined. As of March 31, 2018, the company had approximately $28 million in cash and cash equivalents, which we believe will allow them to fund operations for the dispute resolution as management has indicated that essentially all other activities for the company have been put on hold as a result of the feedback from the FDA.

Conclusion

The news from the FDA regarding Twirla® was not what we had anticipated and we will look for additional updates from the company regarding the path forward. Given the uncertainty surrounding Twirla’s® regulatory pathway we have decreased our probability of approval to 50% and pushed out approval to 2020, although this could change based upon future company guidance. In addition, we believe the company will require more funding than initially thought as the company’s current cash total will likely be used for the dispute resolution. Our current valuation is $1.50.

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