FDA AlignmentThe FDA agreed to consider a BLA based on positive interim trial results from the planned single study, which is considered a particularly positive sign.
Financial PerformanceA discounted cash flow valuation of Longeveron yields a total firm value of $240M, indicating strong financial prospects.
Regulatory ApprovalLaromestrocel has Orphan Drug designation, Fast Track designation, and Rare Pediatric Disease designation, which could expedite its approval process.