The reason for the CRL as indicated by the announcement was the normal requirement of needing at least one well-controlled clinical trial.
If you're truly interested in the facts, you can read through the documents here (https://beta.regulations.gov/document/FDA-2020-N-1539-0022/comment and https://www.fda.gov/advisory-committees/advisory-committee-calendar/august-13-2020-meeting-oncologic-drugs-advisory-committee-meeting-announcement-08132020-08132020#event-materials) to find the relevant information relating the well-controlled clinical trials that is likely to feature in Mesoblast's Type A meeting.
MSB to dispute FDA finding in Type A meeting, page-109
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