What he said is that until the long term survival data, they didn't have the data to discuss with the FDA on the RCT listed in the CRL.
They obviously had that discussion, got an agreed understanding and proceeded to resubmit the Ryoncil BLA = well done and executed.
Now for the product approval
Ann: FDA Accepts Mesoblast's BLA Resubmission for Remestemcel-L, page-211
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