Long term data was not the reason that Mesoblast got a CRL response to their first submission, so why would Mesoblast wait to add this to the response to the resubmission?But the FDA wanted evidence of assays. Without that evidence it still isn't 100% that the survival is linked to the treatment. It could be just dumb luck and the two things may have no correlation.
Ann: Long-Term Survival for Acute GvHD Treatment with Remestemcel, page-23
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