As per standard practice, we don't agree on Mesoblast and it's prospect
But, we can all agree that Mesoblast got to do better with their announcement and provide more clarity for all concerned!
This is my reading of what you've highlighted:
- We (Mesobalst) are working on a new Potency Assays
- This will demonstrate that it's has the same characteristics with those that's is used by the Pediatric P3 trial
- The product uses the same manufacturing process as per what you (FDA) have inspected
- The same product is in our inventory
- The same product will be used for the GVHD adult trial
- The same product will be used for future commercial release of Ryoncil
What this suggest to me is that an AA will be requested for Ryoncil for kids, once the adult trial starts!
Yes, once the trial starts - not when it finishes!
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- Ann: Mesoblast Partners with BMT CTN on Adult SR-aGVHD Trial
Ann: Mesoblast Partners with BMT CTN on Adult SR-aGVHD Trial, page-39
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