Repros Therapeutics Inc. says Androxal is on track to be filed with FDA by year-end and that a cardiovascular outcomes study is not likely needed for approval. Yet, the large costly trial will likely be a post-marketing reality for the testosterone drug despite the company’s claims that it doesn’t have the same issues as testosterone replacement therapies.
The Woodlands, Texas-based biotech hosted a conference call Nov. 7 to convey to investors the specifics of its recent pre-NDA...
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