Ann: FDA Grants Rare Pediatric Disease Designation for Revascor, page-76

Wow, MSB really leading the way (joke):

Longeveron Granted Orphan Drug Designation by FDA for Lomecel-B to Treat Infants with Hypoplastic Left Heart Syndrome (HLHS)

December 6, 2021

• HLHS is a rare congenital heart defect that affects approximately 1,000 babies in the U.S. per year
• Orphan Drug Designation confers certain benefits and may result in seven year market exclusivity upon approval for this indication if all statutory and regulatory requirements are met
• Supplements Rare Pediatric Disease Designation recently granted by FDA

MIAMI, Dec. 06, 2021 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN) ("Longeveron" or "Company"), a clinical stage biotechnology company developing cellular therapies for chronic aging-related and certain life-threatening conditions, announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for Lomecel-B for the treatment of Hypoplastic Left Heart Syndrome (HLHS), a rare and life-threatening congenital heart defect in infants.