Agree. I believe EAP recruitment & treatment (+ 100 days follow up) was completed long before the single-arm study results received the CR.
However, IMO MSB’s interest in a further revised EAP for aGVHD & funding/ design/ product support of further ‘compassionate use’ protocols at FDA’s urging will likely (and sadly) wane now until FDA’s decision-making processes & the ignoring of ODAC’s recommendation are resolved, as a priority for MSB’s business planning.
Agree. I believe EAP recruitment & treatment (+ 100 days follow...
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