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November 25, 2013
07:02 EDTRPRXRepros Therapeutics granted FDA meeting to discuss Androxal
Repros Therapeutics reported it has been granted a face to face meeting with the FDA to discuss the pivotal Androxal efficacy studies per the announcement of October 22. Prior to the meeting, the Agency will have had the final clinical study reports made available. The meeting will also address the unmet medical need for therapy producing restoration of total testicular function, i.e. restoration of T levels without the characteristic suppression of spermatogenesis by marketed testosterone replacement products. The company will report the outcome of the meeting before the end of February 2014.
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