Sure

... from the poppy plant.

Um, whereas methadone is a very similar molecule, but it's synthesized.

It's created through a, through a, um, through a chemical reaction process.

Um, the majority of our drugs are synthetic, um, or semi-synthetic, but some of them are isolated from a natural source.

A botanical drug is very different.

You're not allowed to manipulate it through column chromatography and strip out molecules and pair them back together even.

Uh, wonder if you could talk a little about this program.

Um, can you talk a little bit about the minimum regulatory requirements and why you felt that was not enough, um, uh, for physicians to trust it and, um, and, and credibly prescribe it? Can, can you talk a little bit about that?

Yes.

Well, you know, I think that, that it's important to name the industry and the, the regulatory standards that come with the industry that hemp and, and CBD-based hemp products, um, have really been forced into.

Um, they are, um, it really even quasi-regulated as dietary supplements.

And the FDA not only handles drug approval and approval of medical devices, um, it also regulates, um, food and dietary supplements.

It's the Food and Drug Administration.

And the, the general rules for dietary supplements are the bar is, is, is quite low.

So how can real world evidence and observational data help guide the clinical development of botanical therapies? And if there are any limits, um, I'd like to hear about some of that.