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clock Created with Sketch. 05/10/20
10:52
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Originally posted by Medicalcentral:
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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
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This discussion needs to be bumped.must address.WAY MORE side effects.FDA has acknowledged that there are NO safety issues.
(20min delay)