Ruxolitinib vs Ryoncil

Hey guys I just wanted to create a thread discussing some of the differences between Ryoncil and Jakafi trial results prior to approval/rejection from the fda. From what I understand Novartis did a single arm trial with only a small number of patients prior to approval due to it demonstrating approx 69% overall response rate vs around 30% in the standard care group however there were significant adverse events such as thrombocytopenia, anaemia and cytomegalovirus etc. I get that Jakafi was already approved for other conditions and has a defined MOA but how can you turn down Ryoncil and not Jakafi with their relative safety profiles. Why can’t mesoblast perform a retrospective study on their patients in Japan and use that to support efficacy etc