Dr. Krause has been working behind the scenes with the FDA employees, as he still has good relationships with many of them.
Of course, Mesoblast resubmission material has to stand up, but it helps to have someone with deeper insights in what the FDA are after.
Dr. Krause, along with the rest of Mesoblast was very surprised that the first Ryoncil resubmission failed - but, here we are!
Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA, page-857
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