The P value was quite low, so the odds of a random outcome are also quite low.
Still, it is a post hoc analysis. However, the n is pretty large to go along with that low P value so the ABCLEAR3 analysis is not conclusive, it is very strongly suggestive.
Decisions guidelines? The guideline we have been discussing (or maybe I was discussing something different than what you are discussing) is the FDA AD draft development guidance. I am not aware of any "decisions guideline" that constitutes a strict rubric for the FDA to consider any AD therapy - where can I find that guidance?
Just because you don't like certain guidelines doesn't mean they are outdated. The guidelines were there for a reason. Unfortunately, companies could not create treatments and cures that met those guidelines...not because the guidelines are outdated, but because the guidelines call for real treatments. So instead someone says let's just soften the guidelines to allow any drug to he approved, even if it only helps in an area that will not actually improve the life of the patient.
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