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Re: nidan7500 post# 137221

Saturday, 01/13/2018 8:45:56 AM

Saturday, January 13, 2018 8:45:56 AM

Post# of 462124
Well, MY, MY , MY...what have we got here...?

• Explore the development of a policy framework under which an accelerated approval approach could be used to support marketing of a drug that demonstrates a survival benefit early in clinical development. The goal is to expedite availability of a therapy while the magnitude of the benefit it provides is being confirmed



These rules suggest exactly the opposite of longer, bigger, more expensive, statistically blah, blah, blah sample size blah, blah blah, ...not in our lifetime blah, blah, blah, BTW...IMO, blah, blah modeled trials. Can ew say...Real World Evidence?



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