Capricor disputes FDA post-hoc analyses of deramiocel data ahead of July 29 advisory panel - CAPR News | RalliesCapricor disputes FDA post-hoc analyses of deramiocel data ahead of July 29 advisory panel
C
CAPR• Capricor responds to FDA briefing materials ahead of advisory committee
- Capricor issued a rebuttal to FDA briefing materials ahead of a July 29 advisory committee on its deramiocel BLA in Duchenne muscular dystrophy.
- Management said it responded to all FDA requests and that results are governed by SAP version 3.0, finalized before unblinding.
- It challenged FDA post-hoc analyses as based on SAP version 1.1, described as an unsigned, incomplete internal draft later made obsolete.
- Capricor said Phase 3 HOPE-3 met its primary endpoint, PUL 2.0, with supportive cardiac function benefits.
- Slides were posted on its website to frame the discussion for stakeholders ahead of the meeting.
•
