For me it's a simple materiality test. Did FDA raise anything that outweighed: the Protocol MSB-GVHD001 met its primary objective; the Day-28 ORR was 69.1% (95% CI: 55.2,80.9) in the FAS. The primary endpoint results in MSB-GVHD001 were statistically significant,the measured response was durable (median 54 days), and the results were consistent across subpopulations and secondary efficacy endpoints.
MSB Trading - Aug 2020 on, page-1286
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