Gary Brecka

But sometimes they do say, look, there's this thing in animal studies, we're seeing this dramatic change.

improvement, and maybe it's got some promise.

Well, those are the applications we want to put at the front of the line.

And so we're proactive.

Are you accelerating the process of the applications?

You know, at the Maha Summit, you talked about a very specific case.

I can't recall the specific case, but there was a, I think you were actually reading about a therapy.

Yeah, and the FDA reached out to this company and said, hey, we'd like to fast track you.

I mean, that's unheard of.

Yeah, a form of congenital deafness.

Congenital deafness, that's what it was.

So in the New England Journal, they report that about 12 kids got this gene therapy, and three of them were able to get normal hearing.

Wow.

And I think another seven got improvement in hearing.

Well, what are we waiting for?

These kids are deaf, right?

So we reached out to the company and within a matter of days, we were able to issue them a national priority review voucher to get a decision out in weeks once they submit their data.

And is this national priority review, is this something new at the FDA?

Is there like a, can I use this term, fast track system now where we're, you know, companies with novel therapies that have some evidence based.

And, you know, we talked about blood filtration, for example.