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News For RPRX From The Last 14 Days
Check below for free stories on RPRX the last two weeks.
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May 22, 2013
20:03 EDTRPRXRepros Therapeutics says FDA recommends Phase 2b trial of Proellex-V
Repros Therapeutics announced it has met with the FDA regarding the clinical development of Proellex-V, the vaginally administered product, in the treatment of uterine fibroids. The FDA recommended that a Phase 2b study should be conducted as a prelude to the Phase 3 program. The study will start in the latter half of this year and results are expected in mid-2014. The FDA also felt the studies should be one year in duration. The company was already planning large one year safety studies as part of its overall clinical package. NDA submission is expected in 2016. The outcome of the meeting does not materially affect the cost of the total development program, but it does reduce the cash requirements for Repros through 1Q14.
May 10, 2013
09:26 EDTRPRXRepros Therapeutics reports Q1 EPS (41c), consensus (35c)
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