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
point, um
number you know, Billy Dunn says to Aaron and his colleagues on November, you know, the discussion of amyloid as a surrogate has not is off the table, not a topic.
You can find that in the transcript.
I have an essay in Nature uh Reviews Neurology where we quote page and verse.
Um but it turns out actually
And June of twenty nin of twenty twenty.
conversations between FDA and biogen.
we're on just that topic.
And number two, when Aaron and his colleagues heard the presentation in November, which he's described
The FDA's statistician, um, Tristan Mazie had issued a detailed report critical of the st standard approval, and there was never a discussion of that report, minimal discussion of that report.
Tristan s himself certainly never presented.
Moreover moreover, since the decision, FDA has issued memos that describe
uh real time memos prior to the decision, the internal dis discussions, and in addition Pam Bellick and the New York Times earlier this week published a more detailed uh investigation.
And it turns out FDA was deeply divided.
That summon FDA wanted standard approval.
Others opposed standard and accelerated and still others viewed s accelerated approval a as a sort of compromise in some sense.
So you had three different competing opinions in there.
And then to add to the
Intrigue.
Um the need for congressional hearings, quite frankly, the need for the office of inspector general.
Showing 841–860 of 1,378 · page 43 of 69
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