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Repros Therapeutics Inc. Message Board

  • be_careful_outdere be_careful_outdere Oct 7, 2009 1:07 PM Flag

    Wedbush also reit underperform

    Wedbush says although Androxal demonstrated efficacy in elevating sperm counts into normal range after 3 and 6 months of treatment, Androxal was only effective in 7 out of 16 men treated with drug in increasing testosterone levels. They emphasize that the sample size of this study is very small. Firm says they developmental and regulatory pathway for Androxal remains unclear. The firm notes the company previously attempted to pursue a hypogonadism label for the drug but during a Type C meeting with the FDA in October 2007, it was determined that endpoints associated with male libido and sexual dysfunction were not appropriate clinical endpoints. As such, the company intended to focus Androxal's development in hypogonadal men with metabolic issues. Now, the company hopes to submit a request for a meeting with the FDA to determine whether today's findings are clinically relevant and to design a development program to confirm the findings. Firm reits UnderperformWedbush also reit underp

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