Thanks very much for posting - it is always interesting to read these reports and check your own thinking. I must say that there are a few things in the report which raised my eyebrows though. I think in some parts they are just plain lazy - simply quoting verbatim from MSB releases and re-badging it as their own view. Also there are glaring errors of fact - the FDA requested another trial to address "effectiveness" not "efficacy" (which BTW was what ODAC commented on). These are not merely synonyms and the difference IMO calls into question the likelihood of scenario 1 (accelerated approval). Having said that, I think they are probably correct in revising their assumptions (key assumption change number 1). I am surprised that they had POS 100% against Ryoncil for paediatric SRa-GvHD (that just seem naive) so maybe 70% still too high as well. Might go through the rest of the numbers over the next week if I get a chance. DYOR and GLTAH
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