Dare Bioscience
dare regulatory strategy following clinical development dar intends to leverage the existing safety and efficacy data on the active ingredients in dare estradiol and progesterone to utilize the food and drug administration pathway to obtain marketing approval of dare in the dar intends to seek approval of dare for the treatment of moderate to severe due to menopause in women with intact uteri based on communications with the and the topline data from the dare phase study dar believes approval of dare for that indication is achievable via the pathway supported by a single placebo controlled phase clinical trial of dare and a scientifically justified bridge via a relative trial between dare and the selected listed estradiol and progesterone drugs ongoing activities to support progressing directly into a single phase study to support registration include manufacturing and non clinical studies to support the submission and the planned opening phase study dare strategy | Dare Bioscience
Company
Deck date
February 2023
Slide
42 of 54
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