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Fosco1

11/11/20 1:37 PM

#2506 RE: timberwolf7 #2505

ok timber
you can still state trial arm is effective
but how can you state it is effective if you do not have anything to compare with
you need to compare to standard of care arm. but if your standard of care arm only has few patients to compare with, it is very difficult to state objectively that your trial are is "better". Better to what ?
You can compare with historical data from litterature, but then that's not the original design of the trial. You need to negociate with FDA to demonstrate effectiveness
I guess we just have to wait and see how this comes out