JCR manufactures a product called TEMCELL under license from Mesoblast (originally Osiris). I assume the manufacturing process is pretty consistent with Osiris' original Prochymal "recipe".
I'm pretty sure that when Mesoblast says Ryoncil has been administered to more than 1100 people, they will be including the TEMCELL recipients.
I expect this cohort to be a strong positive for the upcoming FDA decision, given that the patient numbers have been increasing strongly in Japan since first approved. This growth wouldn't be happening if doctors weren't seeing good (or great) results. And it is obviously a no-brainer risk vs reward proposition (safety vs clinical benefits).
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- Ann: FDA Advisory Committee Sets Review Date for Remestemcel-L
Ann: FDA Advisory Committee Sets Review Date for Remestemcel-L, page-324
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