I agree RMAT is a big deal and if other companies had as many as we do, we'd multiples of our current share price. I think everyone is one bitten twice shy and in this case 4x bitten even with a passed phase 3 trial, the other 3 all have really good data on secondary endpoints.
the key for me is the acceptance of the new assay, and we'll know probably as early as next week if the high level data is accepted by the FDA is it game on. That assay drives the ards trial, and may very well be capable of being used on MPC as well as the MSC.
I don't know if everything needs to be addressed from the original submission or just the crl items for approval to be provided on the CMC items eg does the original 9-1 vote still apply?
MESO watch and banter, page-45
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