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@LonSchneiderMD #Adcom
DR. THAMBISETTY: I want to clarify whether
or not this question includes effects of the
biomarkers related to brain pathology as well as
reading out clinical effectiveness because those
are two completely different questions. I want to
be sure I understand
that the question is capturing one or the other, or both in this.
DR. FOUNTAIN: I think 1 understand the
question, and I think we can ask the FDA if we're
undecided, but I think we get to decide that. And
I think the question crosses anything you think
might be pharmacodynamic
mostly related to what I would call biomarkers that we talked about in the discussion.
DR. THAMBISETTY: If I think that there's
good biomarker evidence for brain pathology but not good biomarker evidence for clinical efficacy, how would I vote on this question?
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