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- FDA advisers vote against approval of Capricor’s DMD therapy in chaotic adcomm meetingDuring a perplexing advisory committee meeting in which FDA reviewers focused largely on the Phase 3 HOPE-3 trial’s secondary endpoint of cardiac function, experts pointed to “very fragile” data. T…BioSpace · 1d ago↗ source
- FDA says Replimune’s melanoma data package is ‘not interpretable,’ setting up tough adcommThe FDA's rebuff of Replimune comes a day after the agency similarly called into question the Phase 3 trial for Capricor’s Duchenne muscular dystrophy cell therapy.