Karl Thiel

You cannot accept any new drug application that requires a user fee payment, because literally, there's nobody to operate the till.

If you're trying to submit a new drug, you can't do it during

the shutdown.

This is one of those things that if the shutdown is a few weeks, hopefully that doesn't impact things too much.

Obviously, the longer that drags out, the more serious that gets.

Companies that already have pending applications for the most part should be okay.

Companies that are looking at making new submissions a little further out, hopefully, will be back in business by then.

But there is a little awkward period right now.

I will say, there's some mitigation to that as well.

If you're a company that's trying to submit a new drug application that is for something already approved, to pick a random example, Ionis has said this year that they're going to submit

an approval for a drug called Tringolza, which is for high triglycerides.

It's already approved for a rare disease, and because this is therefore a supplemental application, it doesn't require a user fee, and they should be able to submit that on the normal schedule.

So, that's the sort of good news and bad news on that.

And then, I think the other biggest impact for the industry has been all the NIH budget cuts and grant issues.

And again, that's sort of a good news, bad news story.

The impact on it is really at the top of the funnel for research, which is that a tremendous number of ideas come from NIH research.

And just to pick an example, you can come up with these stupid sounding studies that NIH is doing.

It's like,

Why are we paying taxpayer money so somebody can study the diet habits of the Gila monster in the Southwest or something?

That's, in fact, where GLP-1 drugs come from, is that early, early research.