Longeveron Announces Type C Meeting With U.S. FDA Regarding Pathway to BLA for Lomecel-B In Hypoplastic Left Heart Syndrome
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Longeveron has announced a Type C meeting with the FDA regarding the pathway to a Biological License Application (BLA) for Lomecel-B in treating Hypoplastic Left Heart Syndrome. The ongoing Phase 2b clinical trial, ELPIS II, is considered pivotal for potential full approval.
September 03, 2024 | 1:03 pm
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Longeveron's meeting with the FDA regarding the BLA for Lomecel-B in Hypoplastic Left Heart Syndrome is a significant step. The Phase 2b trial, ELPIS II, is pivotal for potential approval.
The FDA meeting and alignment on trial endpoints and requirements are crucial for Longeveron's BLA submission. Positive trial results could lead to full approval, likely boosting LGVN's stock.
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