Well, the FDA disagree almost the entire MSB hotcopper board. They are clear that Mesoblast do NOT have Orphan drug designation for adults, let alone High-Risk adults with aGvHD: https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=214805
Good luck with treating 15 kids each quarter - at least your exit liquidity at lower and lower prices is good!
Ann: CYP-001s FDA Approval Pathway Not Impeded, page-8
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