By David Bautz, PhD
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On June 7, 2018, Agile Therapeutics, Inc. (AGRX) announced that the company has filed a formal dispute resolution request with the FDA in regards to Twirla®, the company’s once-weekly low–dose combination hormonal contraceptive patch that has completed three Phase 3 clinical trials. As a reminder, Agile filed an NDA for Twirla® in the first half of 2017 and received a complete response letter in Dec. 2017. Following a Type A meeting with the FDA, the official meeting minutes stated that the agency still had significant concerns regarding the adhesion properties of Twirla® that could not be addressed through the company’s proposed patient compliance program. Agile disagreed with this assessment and thus has begun formal dispute resolution proceedings.
We believe the dispute will be reviewed by the Office of Drug Evaluation II and that the company will have a meeting with the Office Director. This meeting is supposed to take place within 30 days of the dispute resolution request. Following the meeting, the Director will have 30 days to provide a decision.
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.
In addition to announcing the submission of the formal dispute resolution request with the FDA, the company also announced that it is reducing its workforce by approximately 30%, primarily from commercial and clinical operations, as a means to conserve cash during the resolution process. We now anticipate the company’s current cash reserves will fund operations into the second quarter of 2019.
We will be very interested to hear the outcome of the meeting with the Office Director regarding Twirla® and based on the 60-day turnaround for the meeting and response we believe the company should be able to provide an update before the end of the third quarter of 2018. While unfortunate, the reduction in workforce will provide the company with additional time to work through the resolution process, which is very difficult to predict the outcome of at this point. Our valuation remains at $1.50.
By David Bautz, PhD