Agile Therapeutics, Inc. Meets With FDA on Comparative Wear Study of Twirla® and Xulane®
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
PRINCETON, N.J., Dec. 13, 2018 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc., (Nasdaq: AGRX), a women’s healthcare company, today announced that on December 11, 2018, it met with the U.S. Food and Drug Administration’s (“FDA”) Division of Bone, Reproductive, and Urologic Products (“DBRUP”) to discuss the design of a comparative wear study between Twirla® and Xulane® (the “comparative wear study”) as suggested by FDA’s Office of New Drugs (“OND”) in its decision on the Company’s formal dispute resolution request, which was announced in October 2018. The Company plans to discuss the results of the meeting in more detail after it receives the final meeting minutes from the FDA in January. The Company met with DBRUP on December 11, 2018 in order to discuss the specific design and success criteria of the comparative wear study. In general, the Company expects to conduct a crossover wear study in healthy women with a Body Mass Index (BMI) less than 35 kg/m2 who will be randomized to
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