Thelma, I am not sure whether your apparent question is directed to the MNDA or myself?

I continue to wonder whether the data they are analyzing is the French data; one might say, since their study was challenged on the basis of ethics by a researcher in the U.S., they would be wise to allow an independent authority to do the analysis. Such authority may have never met ANY of the patients . . . there are not many authorities in this area to begin with . . . imagine you were one and they gave you 'all the data,' via computer, and asked you to do the analysis. So you do the best you can . . . .

Such would improve the ethics posture of the trial but may opportune errors unlike those discoverable in nearly venues of research. You likely would only know the patients by some code rather than name.