Great post @JSBStrikesBack. As a side not I would be interested to know peoples thoughts on whether they think the outstanding CMC issues for Rem-L outlined above by the poster is the main reason why the next COVID - ARDS trial has not progressed in any meaningful way that I am aware of with their collaboration partner the NIH (who will also fund it)? I think the NIH will not move forward with the next COVID - ARDS trial until these potency and quality attributes for Rem-L are given a formal tick of approval from OTAT? Would assume things would move forward quickly with the next trial assuming it is still a key focus for Mesoblast.
BLA resubmission for children with SR-aGVHD, page-2
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