Repros Granted Type B Pre-NDA Meeting With FDA In First Half Of November

(RTTNews) - Repros Therapeutics Inc. (RPRX) said Friday that it has been granted a Type B Pre-NDA meeting with the FDA in the first half of November.

In this meeting the Company will seek guidance on its planned New Drug Application (NDA) for Androxal for the treatment of secondary hypogonadism with preservation of testicular function. Repros believes that the NDA for Androxal will be filed around the end of 2014.

Andre Guay, Clinical Professor of Medicine (Endocrinology), Tufts University School of Medicine, Boston, MA, said, "This news is encouraging as Androxal, in my mind, is a compound that is not another form of exogenous testosterone replacement, but rather stimulates the body to make its own testosterone in men with secondary hypogonadism, which is the most common type of hypogonadism (approximately 80%), by our research and that of the European Male Aging Study."