I don't think you can have an EAP without FDA approval - so FDA are involved
This is a material annc, not necessary in $$$ terms, but maimly publicity through compassionate grounds
... Now step back and think...
Mesoblast got so much on their plate - Why would Mesoblast be involved now on another EAP?
IMO - further good news from FDA coming e.g. earlier review/ approval of Ryoncil to facilitate label extensions for Covid-19 treatments- it just makes sense to mePath if least resistance for FDA
Multisystem Inflammatory Syndrome in Children (MIS-C), page-37
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