@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?
DR. FOUNTAIN: You'll have to decide for
yourself if that constitutes strong evidence of a
pharmacodynamic effect on Alzheimer's disease
DR. THAMBISETTY: So you think the
term "pathophysiology" would also include treatment effects and therapeutic efficacy?
DR. DUNN: Dr. Fountain, you may
intentionally be not wanting me to clarify
DR. FOUNTAIN: would be great if
you'd clarify.
DR. DUNN: Okay. It's always interesting to
work on questions hard and then see how people read them. This question was absolutely intended to represent
the biomarker-based assessment of the
pathology of AD. Really, we're talking
about amyloid and tau, and there was also obviously some downstream effects, not specifically. But that's what we're talking about here, mainly amyloid. But it's not a clinical meaningful question.
It's about what effect has been demonstrated using the biomarkers that we have on the pathophysiological findings.
DR. THAMBISETTY: Got you. So no relation
whatsoever to clinical effectiveness and the
biomarker profile.
DR. DUNN: Yes. I'm wondering maybe if the
word "strong" is
what's got you thinking that.
DR. THAMBISETTY: Exactly. Exactly.
DR. DUNN: Yes. That's really meant to speak to the evidence on the marker itself. So you
can probably pretty easily envision a marker that
has in the abstract, a random drug might have
some of what you might think
of as weak evidence on a marker, and this is really meant to get at the type of thing that Dr. Gold was commenting on
before, and I think you were as well.
DR. THAMBISETTY: because we know
that PET imaging of amyloid does in fact measure
amyloid, but that's not the question
that we're being asked.
DR. DUNN: Yes.

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