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well isn't the real issue one of, why

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timberwolf7   Wednesday, 11/11/20 12:48:45 PM
Re: Fosco1 post# 2504
Post # of 2552 
well isn't the real issue one of, why wouldn't the results be replicated??

Its a rather very straight forward trial, almost a 'go-no go' trial to a degree in that it either works or it doesn't..

and it appears easy enough to confirm whether or not it does.

Bottom line is, if the data in the trial arm is valid data, and the control arm fails to support the trial due to the current standard of care being what it is...

Not sure what your issue is with respect to them asking the FDA for early termination... Now I will agree, IF the data/effectiveness seen is questionable in that its not doing what they are looking for it to do, yeah, I would expect the FDA to say, redesign or continue the trial to completion..

But that does not seem to be the issue based on what they are indicating...

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