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FDA Questions Credibility of Repros Testosterone Pill Data

THE WOODLAND, Tex. ( TheStreet) -- Just last month, Repros Therapeutics (RPRX) and its CEO Joe Podolski assured investors the FDA would find nothing wrong with the clinical data supporting the company's testosterone-boosting pill Androxal.

Repros is "completely satisfied that all data entered into the data base for study ZA-301 will pass any scrutiny the FDA chooses to apply," the company said in a Sept. 18 press release. ZA-301 was one of two phase III studies of Androxal.

In the same release, Podolski added, "We are confident in the reliability of our results and the positive outcome of our two clinical trials."

Podolski's September promise about the high quality of the Androxal data helped Repros shares climb to four-year high.

You know where this story is going, right?

Shares of Repros are down 29% to $16.83 Wednesday after the company admitted that FDA has raised concerns about the reliability of some of the Androxal clinical data collected during the conduct of the phase III studies. Repros is now trading where it did in June, before the big biotech summer rally began.

The FDA told Repros "to request a meeting to discuss the adequacy of studies ZA-301 and ZA-302 as evidence of pivotal efficacy," the company disclosed.

As a reminder, these are the studies of Androxal in which Repros previously admitted that one enrolling site fabricated clinical data, while another site collected anomalous data due to Gay Cuban men having too much sex. Questions have also been raised about whether or not the Androxal studies actually met their sperm-count reduction non-inferiority endpoints.

While Repros figures out if the collected data on Androxal are acceptable to the FDA, the company is pushing back its timeline for filing the drug to the third or fourth quarter 2014. Previously, Repros said it would file for Androxal's approval in the middle of next year.

The new risk is Repros may have start from scratch with Androxal clinical trials. In its announcement Wednesday, the company tried to soften the blow by proposing new studies which would compare Androxal to currently approved testosterone replacement therapies.

The idea of head-to-head studies prompted sell-side analysts who parrot every word uttered by Podolski to start salivating like dogs given a bacon-wrapped bone.

Lazard analyst Josh Schimmer told clients in a note that "the slight delay to tighten Androxal filing is worthwhile."

Brean Capital analyst Jon Aschoff blew off the FDA's concerns and said the latest Androxal data twist "could be positive in the end."

Androxal is a variant of the female reproductive hormone Clomid which Repros is developing as a treatment for men with low testosterone. Right now, men with "low T" are prescribed various testosterone-laden gels and creams -- Abbvie's (ABBV - Get Report) Androgel, Auxillium Pharmaceuticals' (AUXL) Testim or Eli Lilly's (LLY - Get Report) Axiron. The worldwide testosterone market is $2 billion annually and growing but these rub-on treatments are messy, carry the risk of transference and cause sperm counts to fall. (A big negative for men who still want to father kids.) As a pill, Androxal is designed to be much more convenient, can't be transferred to kids or women, and most importantly, doesn't lower sperm count.

-- Reported by Adam Feuerstein in Boston.

Adam Feuerstein writes regularly for TheStreet. In keeping with company editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback; click here to send him an email.

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