Dr. Holly Fernandez Lynch

It was controversial because both that endpoint seemed to be a bit dicey.

Right.

There was a lot of discussion about whether it was even reasonably likely to predict clinical benefit.

The the company had also tested that drug.

against the clinical endpoints, those things about how the patient feels, functions, or survives.

And it turned out that the drug wasn't able to demonstrate benefit on any of those.

The company relied on these plaques in the brain as kind of a backup to get the product approved.

FDA is able to call on outside advisors, outside experts to weigh in on these kind of challenging drug approval decisions.

And they called this advisory committee together.

Everybody but one person who abstained said to FDA, no, the standard has not been met here.

Do not approve this drug.

And FDA went ahead and approved it anyway, despite a lot of concern about whether or not it worked.

So it's really kind of held up as evidence.

I was going to say a shining example, but whatever the opposite of shining is, the tarnished example of the kind of drug that really should not be approved.

But there are other circumstances where FDA grants flexible approvals, where the evidence is a bit uncertain.

But when you're facing a serious disease with no good treatment options,

It makes sense for FDA to be able to exert a bit more flexibility.

We just want to make sure that that flexibility doesn't go overboard so that we can have confidence that when our doctor prescribes us an FDA approved drug, that it is reasonably likely to benefit us based on strong evidence.

So there are a lot of different parties involved here, right?

So you might hear folks talk about a drug manufacturer or a drug sponsor, right?