With regards to the clinical plan, the Company proposes that the drug be studied per ICH recommendation, which includes: two well designed pivotal studies, 100 subjects dosed for one year, 300-600 subjects dosed for 6 months and 1000-1500 subjects dosed for any duration at any dose. The Company plans to pool the safety data base from the IND for Androxal in the study of secondary hypogonadism in men wishing to preserve fertility with the Type II diabetes program. The frequency and onset of Type II diabetes and secondary hypogonadism have similar demographics based on age and other conditions and the Company believes the two groups are very similar. Twenty percent of the men in the Company's studies of secondary hypogonadism were also confirmed diabetics.

Previously, in a subset of hypogonadal men with elevated glucose, Androxal showed a statistically and clinically significant reduction in morning fasting glucose levels while elevating testosterone. With roughly 20 subjects per arm, Androxal doses of either 12.5 or 25 mg achieved a median reduction greater than 10 mg/dl of glucose in men with elevated fasting glucose levels. The change from baseline was statistically significant for both groups, p<0.02. By contrast, neither a commercial topical testosterone nor placebo achieved statistically or clinically significant reductions.

Joseph S. Podolski, President and CEO of Repros noted, "We believe the FDA critique of our Phase II protocol is very constructive. We will incorporate their recommendations. If the study is successful, incorporating the FDA's recommendations will facilitate Phase III studies. In agreement with the FDA we believe the protocol we have designed will determine if there is a clinically significant signal that warrants further development." He commented that before proceeding with the study the Company must raise additional capital and is currently evaluating several different financing options, in addition to the recently announced ATM financing.

Source Repros Therapeutics Inc.