FDA Receives Repros Therapeutics Inc. (RPRX)' Submission for Special Protocol Assessment Documentation for Pivotal Studies for Androxal(R)
5/17/2012 9:58:02 AM
THE WOODLANDS, Texas, May 16, 2012 (GLOBE NEWSWIRE) -- 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 ("PDUFA"), the FDA has 45 calendar days to provide comments back to Repros.
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