Gary Brecka

So we have to sort of review different groups and subgroups and ask ourselves, what is harmless, been out there for a long time and already has an established safety profile?

what is equivalent to a drug in a current phase three clinical trial where we still don't know the results.

On your question about is this the first time we're doing a priority voucher review, it is the first time we're piloting a program to get a decision out in 48 weeks or so.

That's insane for the FDA.

That's amazing.

I mean, they've had programs to get it down, accelerated, breakthrough designated.

There's all these terms that have been out there, expedited.

It sounds great.

Yeah, sounds good.

I hired a permit expediter for my last construction project.

It took me three years.

Yeah, who doesn't like the word expedite?

Yeah, we don't like that word.

But we got to try new things.

The goal of lowering drug prices is such a major goal that if we can lower R&D costs

get more drugs out faster and safer, then we can have more competition.

We're lowering the barrier for generic versions of drugs, especially of the expensive biologic drugs.

Those generic versions are called biosimilars.

And it's been hell for those companies to come to market after a biologic drugs patent expires or market exclusivity expires.

I mean, with Humira, I think it took five years.