Thanks for putting that together
I like this bit.
FDA says...Topic for Discussion #2: The primary endpoint results in MSB-GVHD001 were statisticallysignificant, the measured response was durable (median 54 days), and the study results wereconsistent across subpopulations and secondary efficacy endpoints.
Safety ...THis stuff has been used in Japan for years with no adverse effects.
FDA ODAC Meeting Material discussion analysis, page-10
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