Repros Therapeutics Inc. Receives Official FDA Minutes for Androxal(R) Phase 3 Meeting Held on May 9, 2012
Published: Jun 19, 2012
THE WOODLANDS, Texas, June 18, 2012 (GLOBE NEWSWIRE) -- Repros Therapeutics Inc.® (Nasdaq:RPRX) today announced it has received the official FDA minutes of the meeting held on May 9th to discuss the pivotal and safety studies that will be required to be completed before an NDA for Androxal® can be submitted. The FDA minutes confirm that the specifics for the pivotal studies will be defined under a Special Protocol Assessment ("SPA"). The Company resubmitted the SPA on May 22nd and made an announcement on that same day. PDUFA requirements ensure that the FDA will respond within 45 calendar days of submission.