Geron’s Imetelstat Faces Full Gamut Of US FDA Questions At ODAC Meeting

 
• By Derrick Gingery

FDA has efficacy and safety concerns about the proposed anemia treatment and questions whether the results could even apply to US patients given the large number of ex-US study participants.

blood transfusion
The imetelstat advisory committee documents included separate briefings from the FDA and Geron, rather than a combined package. • Source: Shutterstock

More from US FDA Performance Tracker

More from Regulatory Trackers