Jason Karlawish

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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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The mean mini metals in both studies was around the mid-20s, don't quote me, but like 24 or so.

Uh the cutoff lower end of mini-metal was again 20 or so.

So, you know, that's the kind of the population described.

I had to have elevated amyloid by some measure, CSF or uh PET scan.

Um Denanomab also required a TAW scan value.

uh namely l at least low tau, although the question is whether that would make it under the label.

And I think the depending on who you talk to, it's very interesting, you know, what would you do for people with below low tau or high tau.

Uh we can get into that.

But those are the basics for the drug.

So gotta meet a clinical criteria.

uh which is pretty well described and have this positive biomarker test and then there are uh some safety issues that need to be assessed as well.

Sharon Sharon, you're totally onto it.

I mean Lacana Map has a FDA

They don't like the term, but they put it in the black box.

It's the black box warning.

It's the top of the label.

The label leads with a warning.

And the warning is on the risk of

Uh what I don't like the term, I find it odd, area uh amyloid related imaging abnormalities, H and E, H for hemosiderin or hemorrhage, E for edema.

And exactly as Sharon said, uh it is

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