MSB Trading 2021 - paradigm shift, page-723

The main problem I have with the Jakafi approval has more to do with the baseline response rate they used for SoC that the FDA accepted - 40% of patients respond to SoC. The FDA presented great skepticism of how MSB's SoC baseline was produced and this was one of their major objections in the notes to the ODAC. The MSB SoC response rate for the baseline was 45% (and their single arm result for Rem-L was 68%).
I can't see how the FDA can happily use 40% for baseline SoC response rate and approve a drug with marginal efficacy and then object strenuously to a baseline SoC response rate estimate of 45%, I would have thought that their prior Jakafi approval would have removed all objections to the MSB SoC baseline and established 40% as the FDA agreed figure.