Look the FDA simply said "appears to be sufficient" for resubmission. There is no way that they could determine whether it is sufficient to grant approval or make a decision about an adult trial until after the submission has been examined. Posters here constantly overstate the position, but that's understandable given that SI does the same.
Ann: FDA Accepts Mesoblast's BLA Resubmission for Remestemcel-L, page-258
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