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Longeveron Announces Type C Meeting With U.S. FDA Regarding Pathway to BLA for Lomecel-B In Hypoplastic Left Heart Syndrome
2024-09-03 21:03
- On-going Phase 2b clinical trial (ELPIS II) deemed pivotal and, if positive, acceptable for Biological License Application (BLA) submission for potential full traditional approval
- Alignment with FDA on ELPIS II primary and secondary endpoints
- Alignment with FDA on CMC and Potency Assay plan and requirements
- Alignment with FDA on CMC and Potency Assay plan and requirements
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