FDA simply has more data at its disposal than any individual doctor, no matter how renowned.
I dont know if this is true, but I would think that the previously mentioned docs, combined have a large percentage of CML patients that exist in the U.S. whether in trials or in practice. If true, it would be odd to think, given their huge success in the safe use of Iclusig, that they are just not seeing or "missing" SAE's by virtue of having a cleaner initial patient profile. "Renowned" truly matters...as my comment suggests. Seems the data actually suggests this as well. Top docs already know how to administer Iclusig. Lesser talented docs obviously do not, or they have so few patients in an equally weighted statistical measure that the data is skewed from the beginning.