AGRX - Twirla FDA agree on details for Twirla birth control patch post-marketing requirements
- Twirla and the US FDA have agreed that using electronic health records and insurance claims is appropriate to fulfill post-marketing requirement for Agile Therapeutics ( NASDAQ: AGRX ) Twirla birth control patch.
- The agency also agreed to extend the study timeline.
- Interim safety data is due in November 2029, with a final report in November 2035 .
- Agile ( AGRX ) has paused all work on its pipeline since 2021 to focus on Twirla commercialization.
- Seeking Alpha's Quant Rating views Agile ( AGRX ) as a strong sell.
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Twirla, FDA agree on details for Twirla birth control patch post-marketing requirements