the FDA make that determination when the re-submission is made by Mesoblast.
but we can clearly see this is a class 2 CRL... they are asking for another trial.
Not something we can whip up in a couple of weeks and resubmit. the new trial they want could take a long time to recruit, especially if they want kids in a RCT... it may not even be possible.
MSB to dispute FDA finding in Type A meeting, page-195
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