Conflicts of Interest Disclosures: KMB is a consultant to Mesoblast, Inc. EB is an employee of Mesoblast, Inc
One of the authors is a consultant to Mesoblast and the other is an employee.
It's a "case study", the second lowest form of evidence which ranks one notch higher than expert opinion, the lowest form of evidence.
I don't think that's going to sway the FDA. They heard many anecdotes and expert opinions at the ODAC meeting. Its just not sufficient to try and short cut scientific investigation that way. Its too easy to be misled and swayed by emotional arguments which turn to be nothing more than some one's belief.
Ann: Remestemcel-L for COVID-19 MIS-C published in Pediatrics, page-88
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