Saturday, December 30, 2017 9:12:51 AM
Based on your govt./FDA process experience was the hold up driven by politics ( FDA/BP/local/US) or FDA insiders not being able to chew gum and walk at same time? A real puzzle when the new boss (Dr. G.) says something wonderful is about to happen/w/time lines and then ZIPPO. He must be pissed or is it a processing/control point he just missed?
IMO, they got started and then the new information compelled them to hold up considering the consequences (good/not good). Mindful that they were evaluating variables in context of AD which have never been analyzed. Also, what is your opinion on the large academic and 3rd party support for A2-73? Not one doubter in the whole bunch...thoughts??
My own experience is these guys do not miss dates. The whole precision medicine initiative (balloons/bells/whistles and all) ran out of runway.
What do you think happened?
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