Longeveron Inc.
laromestrocel (LOMECEL-B®)
hypoplastic left heart syndrome (HLHS)
Date
TBD
Advisory committee · Date TBD estimated
What's at stake
An FDA advisory committee reviews laromestrocel (LOMECEL-B®) for hypoplastic left heart syndrome (HLHS) around Date TBD. The panel's public vote often front-runs the agency's final verdict — and the share price.
Primary source
· SEC 8-K
verified 13h ago
“In the Type C meeting, the FDA acknowledged that HLHS is a rare disease associated with significant morbidity and mortality with a high unmet medical need for safe and effective therapies, but also asserted that the primary endpoint of righ”