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Re: Doktornolittle post# 54633

Monday, 02/22/2016 12:19:18 PM

Monday, February 22, 2016 12:19:18 PM

Post# of 719872
Hey Dok, the 'dream' you speak of -- 1st interim approval -- might wait 3 to 5 months after sufficient enrollment, like Tariquidar did (Just using it as a protocol example, not a result example), or wait for the second interim to allow time for the last enrolled patients to also have sufficient time for observation, to allow time for the secondary endpoint to draw nearer to completion before accelerated approval (FDA Guideline style), and to allow greater development of all subgroup statistics. It's impossible to say what is going on right now, but that is the "dream" scenario, IMHO.


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