Remember Lassman wants the FDA to reject our BLA? They wanted us to do a proper randomized control trial? KARMA is a bieetch, I believe it is likely that the FDA will approve Ryoncil for children SR aGVHD, but I could see a phase 4 RCT trial to treat the adult population as one of the requirement for approval. The Lassman wanted a RCT, i think they will get it!!! And as I mentioned earlier Jakafi's efficacy is rubbish especially for those patients with grade III and IV disease. I think SI is more than happy to conduct the extension trial together with the FDA.
Ryoncil: ODAC/FDA Meeting Discussion, page-1991
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