Repros Receives FDA Guidance Regarding Clinical Program for Androxal
Repros Therapeutics (NASDAQ: RPRX) today reported it has received guidance from the FDA regarding its clinical program for Androxal.
The Company had previously submitted a list of questions with the final clinical study report for ZA-301. Repros subsequently provided an update of topline results from ZA-302 to the FDA.
The primary purpose of the requested teleconference is to determine if Site 9 (men referred from a fertility clinic) should be included in the final analysis of Study ZA-301. Study ZA-301 was not originally powered to allow for exclusion of Site 9 from the calculation of non-inferiority versus placebo for drops in sperm counts. However, Study ZA-302 was powered for analysis with or without Site 9 and met the co-primary