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  "documentTitle": "Dare Bioscience | Investor Presentation Deck | 54 slides",
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  "authorName": "Daré Bioscience",
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  "presentationDate": "2023-02-01 00:00:00",
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  "notes": "The slide details the specific regulatory strategy for a pharmaceutical product, focusing on the 505(b)(2) pathway.",
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      "text": "Daré intends to seek FDA approval of DARE-HRT1 for the treatment of moderate to severe VMS due to menopause in women with intact uteri.\n\nBased on pre-IND communications with the FDA and the topline PK data from the DARE-HRT1 Phase 1 / 2 study, Daré believes FDA approval of DARE-HRT1 for that indication is achievable via the 505(b)(2) pathway supported by a single, placebo-controlled, Phase 3 clinical trial of DARE-HRT1 and a scientifically justified PK “bridge” (via a relative bioavailability trial) between DARE-HRT1 and the selected listed estradiol and progesterone drugs.\n\nOngoing activities to support progressing directly into a single Phase 3 study to support registration include manufacturing and non-clinical studies to support the IND submission and the planned IND-opening Phase 3 study.",
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      "text": "Following clinical development, Daré intends to leverage the existing safety and efficacy data on the active ingredients in DARE-HRT1, estradiol and progesterone, to utilize the U.S. Food and Drug Administration’s (FDA) 505(b)(2) pathway to obtain marketing approval of DARE-HRT1 in the U.S.",
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      "text": "1.Anticipated regulatory pathway and timelines.",
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      "text": "DARE-HRT1 - U.S. Regulatory Strategy",
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