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February 11, 2013
09:29 EDTRPRXRepros updates Adroxal study, requests end of Proellex Phase 2 study
Repros Therapeutics provided an update for both of its core clinical programs. As part of the FDA requirement for total number of subjects to be exposed for six months, the company is conducting a 500 subject open label study. To date, the company has enrolled 499 subjects and expects the study to be fully enrolled this week. The company has sent a "request for guidance" letter to the FDA. The key points were the identification of a single high enrolling site with a population whose baseline characteristics appear different from the other sites; the company has proposed enrolling an additional 40 subjects into each of the two pivotal studies to allow for subset analysis while retaining the power of the original protocols; the company proposed moving two sites from the enrolling study ZA-302 to the closed for enrollment study ZA-301. When the company receives guidance from FDA, it will update the financial community. The company has requested an end of Phase 2 meeting for its vaginal Proellex program for the treatment of uterine fibroids. The request was for a meeting before the end of April.
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November 30, 2015
07:56 EDTRPRXFDA PDUFA Date for Repros Therapeutics Enclomiphene is November 30, 2015
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