FDA’s Office of Drug Evaluation III Denies Agile Therapeutics, Inc.’s Initial Formal Dispute Resolution Request
Agile Therapeutics, Inc. (AGRX)
Last agile therapeutics, inc. earnings: 5/2 04:15 pm
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US:NASDAQ Investor Relations:
ir.agiletherapeutics.com/investor-relations
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Source: GlobeNewswire
Company Plans to Appeal to the FDA’s Office of New Drugs PRINCETON, N.J., July 24, 2018 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc., (Nasdaq:AGRX) (the “Company”), a women’s healthcare company, today announced that the Office Director of the FDA’s Office of Drug Evaluation III (ODEIII) has affirmed the position of the Division of Bone, Reproductive and Urologic Products (DBRUP) and denied the Company’s appeal of the December 21, 2017 Complete Response Letter in relation to the New Drug Application (NDA) for Twirla®. The Company had appealed the decision by DBRUP that concerns surrounding the in vivo adhesion properties of Twirla prevent its approval and cannot be addressed through the Company’s proposed patient compliance programs. The Company intends to appeal the ODEIII decision to the Office of New Drugs. Agile initiated formal dispute resolution with the FDA’s ODEIII on June 6, 2018 to appeal the December 21, 2017 CRL for Twirla. The appeal was submitted in accordance with
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- Agile Therapeutics, Inc. (NASDAQ: AGRX) is now covered by analysts at StockNews.com. They set a "sell" rating on the stock.MarketBeat
- Agile Therapeutics, Inc. (NASDAQ: AGRX) is now covered by analysts at StockNews.com. They set a "sell" rating on the stock.MarketBeat
- Agile Therapeutics, Inc. (NASDAQ: AGRX) is now covered by analysts at StockNews.com. They set a "sell" rating on the stock.MarketBeat
- Agile Therapeutics, Inc. (NASDAQ:AGRX) Q4 2023 Earnings Call Transcript [Yahoo! Finance]Yahoo! Finance
- Agile Therapeutics Reports Fourth Quarter & Full Year 2023 Financial Results and Provides Corporate UpdateGlobeNewswire
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- 11/9/23 - Beat
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- 4/9/24 - Form 8-K
- 3/28/24 - Form 10-K
- 3/28/24 - Form 8-K
- AGRX's page on the SEC website