I'll give it a go at explaining this...
REMESTEMCEL-L is the base product and has multiple indications.
This has been branded as Ryoncil for the acute GVHD indication.
Ryoncil (for acute GVHD in children) has been registered with the FDA and has gone through a thorough BLA process which has a Prescription Drug User Fee Act (PDUFA) action date of September 30, 2020. That means, the FDA has up to this date to approve Ryoncil or not.
If approved, Mesoblast will make RYONCIL immediately available in the United States = commercialisation.
A little clarification please, page-8
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