An FDA advisory committee's clinical development recommendations for hypogonadism treatments suggests Repros Therapeutics Inc. will face challenges in designing a new study with endpoints sufficient to support regulatory approval of its estrogen antagonist enclomiphene. And the committee’s surprised reaction to FDA’s stringency on patient-reported outcomes (PROs) underscores just how difficult the emerging area can be for sponsors.
Given the panel's emphasis on the need for data on PRO symptom improvement, coupled with its rejection of Repros' proposed...
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on Pink Sheet for daily insights
- Start your 7-day free trial
- Explore trusted news, analysis, and insights
- Access comprehensive global coverage
- Enjoy instant access – no credit card required
Already a subscriber?