Repros Therapeutics To Meet FDA Regarding Talks On Androxal Efficacy Studies

(RTTNews) - Repros Therapeutics Inc. (RPRX), Monday said it has been granted a meeting with the FDA to discuss the pivotal Androxal efficacy studies per the announcement of October 22, 2013. Before the meeting, the agency will have had the final clinical study reports made available. The company will report the outcome of the meeting before the end of February 2014.

The meeting will also address the unmet medical need for therapy producing restoration of total testicular function, that is restoration of T levels without the characteristic suppression of spermatogenesis by marketed testosterone replacement products.

The company said Wayne Hellstrom, Professor of Urology and Chief of Andrology, Tulane University and incoming President of ISSM and Edward Kim, Professor at University of Tennessee Graduate School of Medicine will be present in the discussion.