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  "authorName": "Daré Bioscience",
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  "notes": "Focuses on regulatory strategy and clinical trial design parameters for Phase 3.",
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      "text": "Considerations for the Phase 3 program to be discussed with the FDA: Indication and Patient Population; Primary Endpoint; Duration of Study and Efficacy Assessment Timing.",
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      "text": "Following clinical development, Daré intends to leverage the existing safety and efficacy data on the active ingredient in Sildenafil Cream to utilize the FDA's 505(b)(2) pathway to obtain marketing approval of Sildenafil Cream in the U.S.",
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