Repros Therapeutics (RPRX) tumbles 32% premarket after outlining new FDA guidance for Androxal.
The regulator wants a meeting to discuss Site 9's inclusion in the ZA-301 analysis. RPRX notes that "ZA-302 was powered for analysis with or without Site 9 and met the co-primary endpoints in both instances." (PR)
Ultimately, RPRX is now guiding for an H2 2014 NDA submission — that looks like a delay from previous guidance of mid-2014.