Cell Therapy News/Articles, page-16611

Lucky for the FDA, Mesoblast has completed one adequate and well controlled trial, that coincidentally also achieved the primary end point.
GVHD001.


Had the FDA told MSB in the CRL that your trial was not adequate or controlled, there is no way on earth FDA would have would have used the phrase recommend another trial. Either it is above the standard or not. FDA did not require another trial, therefore they must have assessed the trial as both adequate and controlled. Further backed up by the CRL resubmission being accepted.

Whatever MSB have provided FDA so far, clearly the FDA think they are on the right path, so the hail mary in this case are the shorts that are praying for a miracle second CRL.