Repros Therapeutics Inc.
Repros Receives Guidance from FDA Regarding Continued Development of Androxal(R) in Hypogonadal Men
Published in Medical Letter on the CDC and FDA, February 14th, 2010
Repros Therapeutics Inc. (NasdaqCM:RPRX) announced that the Company and its consultants participated in a teleconference with the Division of Reproductive and Urologic Products of the FDA on January 25, 2010. The primary purpose of the meeting was to gain a better understanding of the FDA's position regarding the use of Repros' oral Androxal® product in the treatment of men with secondary hypogonadism wishing to preserve their fertility. The Company's data supports the notion that the negative feedback of exogenous testosterone administered by any route suppresses the hypothalamic-pituitary axis and hence spermatogenesis.
The discussion with the FDA focused on two...
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