My impression is that the FDA think the trial is seriously deficient for a phase 3 trial which is why they didn't approve Remestemcel first time around, even after going to the time and expense of convening an ODAC meeting. The resubmission of the BLA almost 3 years later is an attempt to try and persuade the FDA to change their minds. I'm not at all sure they will.
2023 The Final Countdown, page-2129
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