Having reviewed the agenda here
https://www.fda.gov/media/140999/download
A key presenter will be Dr Joanne Kurtzberg she is internationally renowned expert in paed blood and marrow transplantation and Lead Investigator in recent MSB trial on Chronic Graft vs Host disease. IMO her presentation will be significant to convincing the voting panel that this therapy is critical to children under 12 with aGVHD as nothing else that is effective exists.
FDA ODAC Meeting Material discussion analysis, page-303
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