Ryoncil: ODAC/FDA Meeting Discussion, page-1734

Committee Vote: 8 YES and 2 NO

Great job by all the Mesoblast team members today. Very professional presentations. Honorable mention to Dr. Kurtzberg who helped carry the day on the issue of approving based on a single arm study. It's hard to argue against a front-line clinician of her stature who has treated over 30 children with remestemcel-L. She did an excellent job in subdued but effective tones describing the suffering these children go through and the "dramatic" results remestemcel-L affords them. I lost sound at the end when each committee member discussed reasoning behind his or her vote. The two no votes were from an adult oncologist at the NIH who is a hardliner about doing blinded controlled 2-arm trials. The other NO vote came from the patient representative, ie a lay person there to represent patients. I don't know what that is all about, would have liked to have heard her explanation. In any event it's a relief to have this behind us. FDA usually follows committee recommendations. Mesoblast planning to do an adult double-blinded trial in adults I think should provide further sway for the FDA to approve this in suffering children. Looking forward to the first interim read out now on C-19 ARDS. We're in for some exciting times. Many thanks and glta. HODL !!