Repros (RPRX) Gets Confirmation that Required Androxal Phase 3 Documents Delivered
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Repros Therapeutics Inc. (Nasdaq: RPRX) today announced it has received confirmation of delivery of the required documentation for Special Protocol Assessment ("SPA") of its Androxal Phase 3 pivotal studies to the FDA. Per the Prescription Drug User Fee Act, the FDA has 45 calendar days to provide comments back to Repros.
n other news, the Company expects to commence screening subjects next week in a 500 patient open label study designed to demonstrate the safety of Androxal® as well as complete a draft of a one year DEXA study for submission to FDA for review. The Company has initiated over 25 US clinical sites for the open label study and is reviewing which sites will be appropriate for the SPA studies as currently designed. Neither the open label nor DEXA studies are part of the SPA review process.
n other news, the Company expects to commence screening subjects next week in a 500 patient open label study designed to demonstrate the safety of Androxal® as well as complete a draft of a one year DEXA study for submission to FDA for review. The Company has initiated over 25 US clinical sites for the open label study and is reviewing which sites will be appropriate for the SPA studies as currently designed. Neither the open label nor DEXA studies are part of the SPA review process.
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