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Borel Fields

07/25/20 10:20 AM

#98262 RE: tikotiko #98259

I don't have a standard deviation to run p-values - just noting the shape of the distribution (not unfriendly) and what data points have leverage.

Actually, I'm as concerned about the "unknown unknowns," to use an old phrase. For example, in HIV, when thinking about when we would get a PDUFA date, I didn't consider anything about 700mg data being needed from a subsequent trial and how that could be a problem.