Jason Karlawish
speaker
1,378 appearances
5 recordings
1 series
first heard Feb 2021
last heard Dec 2023
Jason Karlawish’s voice in public audio — every appearance, attributed to the second.
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Appearances
So this is about Lacanomab, the Nanomab, two well done phase three trials.
I'm a prescriber.
I think Jerry Trishans need to decide whether they want to get on board as individuals.
Well I'd say two well done.
Well it's each one I think
Again, only one phase three trial.
That was an FDA decision.
We could debate that as a matter of public policy, but I found the trials to be well done, well designed, generally well analyzed, and the data across clinical and biomarker endpoints um are consistent and compelling that the drug is effective.
Um and uh the benefits are there and so too are the risks.
And you know, the Dynanomab data are very interesting because Lily's design for Dynanomab was
Once amyloid positive obviously got the drug, and then once uh their uh amyloid measure fell below a cutoff of centyloids, the drug was stopped, the patients continue to be followed.
So they've introduced an interesting practice here, which is reassess amyloid after a certain period of treatment, and if amyloid is cleared, cease drug um and follow.
And that's gonna be very interesting to see how that unfolds in healthcare practice.
So it does give us an endpoint.
And it also gives us a biological endpoint, which is very interesting as opposed to a clinical endpoint for that decision about whether to stop the drug.
To be known, but we don't know what nature to.
Yeah.
I mean the studies enrolled people met criteria for MCI, cognitive impairment with inefficiencies in daily activities.
So some mistakes, but you caught them.
Um andor mild stage dementia, which is some disability in instrumental activities of daily living.
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