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11/17/13 4:25 PM

#38974 RE: DewDiligence #38973

Not sure about that. Wouldn't the clinical investigators that are on ariad's medical advisory board be privy to all of the clinical data as well as the safety reports? I thought that was the standard program.

Even so, one would expect that the top clinical investigators, especially the Drukers, Corteses, etc. would have more treatment experience than any other physician whether private, institutional or at the FDA. It would only make sense, as there aren't that many CML patients to begin with compared to diabetes, MS, breast cancer, etc. Any "expert" working for the FDA on this would pale in comparison to the ones backing this drug publicly.

This is an orphan drug for a rare disease, let's keep that in mind
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gdollasign

11/17/13 4:42 PM

#38975 RE: DewDiligence #38973

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.