MSB Trading 2021 - paradigm shift, page-1124

I read the submission too - it's even more interesting when you read it in conjunction with the Jakafi one - both single arm trials, Jakafi with a lower null hypothesis of 40% (MSB chose 45%) both of these acceptable to the FDA until MSB's trial comes along and then all of a sudden a) apparently it's not possible to assign an effective null hypothesis for pediatric GvHD (despite accepting Jakafi's 40%) b) single arm trials now apparently aren't acceptable and c) the use of prophylactics confounded interpretation of the MSB results but was totally acceptable in the Jakafi trial. Hmmm....