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Re: leifsmith post# 133699

Wednesday, 06/28/2017 1:31:28 PM

Wednesday, June 28, 2017 1:31:28 PM

Post# of 146291
First NNVC has to pick lead and backup candidates, which they haven't managed to do yet. CMC work is costly and time consuming, so one doesn't just do it for compounds that aren't intended for development.

There's a smaller minimal subset of the total body of required CMC work that's sufficient for the FDA to allow one to get through IND and Phase-I trials. Eventually all of the CMC work has to be completed, but one can delay some major costs until after Phase-I by doing that minimal amount of work. (I'm not a CMC/regulatory expert, but this is what I've been told by such experts).

A casual stroll through the lunatic asylum shows that faith does not prove anything. Friedrich Nietzsche

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