Repros says Androxal achieved both primary endpoints in the study with statistical significance. However, the company left a lot of data undisclosed and questions about the conduct of the study unanswered.
On the testosterone endpoint, Repros says 79% of the intent-to-treat, Androxal-treated men exhibited 24-hour testosterone levels that were in the normal range after 12 weeks, therefore exceeding the 75% threshold.
Repros did not disclose the mean or median testosterone levels for the men treated with Androxal in the study, nor did the company say anything about how the men treated with placebo performed with respect to testosterone levels.
In a separate "completers" analysis, 83% of men treated with Androxal had a mean 24-hour testosterone of 425 ng/dl, Repros said. [The "normal" testosterone range was defined at 300-1040 ng/dl.]If Repros had mean testosterone levels for the "completers" in the study, the company surely has similar data on the more-important intent-to-treat patients, yet this information was not disclosed. [And none of the analysts on the conference call bothered to ask.] Repros provided even less disclosure for the sperm count endpoint, while acknowledging that the conduct of this portion of the study ran into problems. Repros claims that Androxal-treated men with "valid baseline sperm results" had sperm counts 12 weeks later that were non-inferior to placebo patients -- good enough to claim victory. On the conference call, Podolski said 15 men on Androxal had sperm counts that fell below 50% of baseline compared to 1 man treated with placebo. Repros also acknowledged that if the largest-enrolling clinical trial site was removed from the analysis, the sperm-count endpoint failed to reach statistical significance. FDA will examine the sperm count data with and without the data from this clinical trial site, Podolski said. This is also where we get back to the gay Cubans. Podolksi argued that some of the low sperm counts recorded in the study were the result of men having too much sex, and not due to Androxal. He also tried to downplay any negative effect resulting from another clinical trial site where baseline sperm counts were made up or missing. A second phase III study of Androxal is underway, with enrollment expect to wrap in May. Podolski insists the data announced Thursday should convince investors that the second study will also be positive. But what about all the inconsistencies in the clinical trial and and missing Androxal data? "I think FDA will be just fine with these results," Podolski said. And why should investors trust Podolski? "If you're in my kitchen, you may not like the way the food smells, but hopefully, it tastes good," he said. I have no idea what that means, either. -- Reported by Adam Feuerstein in Boston. Follow @AdamFeuerstein
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