Actinium Provides Regulatory Update on Planned BLA Filing and Future Plans for Iomab-B in the U.S.

FDA determined that the Phase 3 SIERRA trial is not adequate to support a BLA filing for Iomab-B despite its statistically significant primary endpointAdditional head-to-head randomized clinical trial demonstrating overall survival benefit with Iomab-B is required by FDA to support a BLA filingActinium to request a meeting with the FDA to further discuss specifics of additional trialActinium will seek strategic partner for Iomab-B in the U.S. following completion of FDA interactions and focus development ef ...