I wonder how JNJ got approval and Eiasi did not. If more patient data points accumulated or if the same data points used? Does anyone know. I wonder if Eisai resubmits to US? I have to feel that treating doctors in EU made the difference. Maybe Eiasi should consult or pay the JNJ team.
At some point in time FDA might have to reevaluate and feel embarrased about its decision. For now, treating doctors most likely treating under their choice with MDS approval.