Capricor disputes FDA briefing materials for Deramiocel as based on outdated plan
Capricor disputes FDA briefing materials for Deramiocel as based on outdated statistical analysis plan
- Company says FDA used an outdated statistical analysis plan in Deramiocel briefing materials for July 29 advisory committee.
- Capricor posts portions of its July 29 advisory committee presentation slides on its website for investors.
- Slides highlight statistically significant HOPE-3 results that Capricor says support Deramiocel’s efficacy.
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