Compass Pathways PLC

Hey, what's up? What's up, everybody? Um, yeah, I mean, I think we've talked about it a lot on this podcast, so I can keep it brief, but, you know, it, it does continue to feel like the FDA's got a door, uh, wide open for psychedelics drugs.

Uh, I mean, the FDA just put out like finalized guidance for drug development, which generally speaking aligns with a number of the clinical programs that we've seen out there from Compass, um, Definium, and others who are in late... mid to late stage development, right? Just as it relates to like twelve-week primary endpoints, re-dosing, like, you know, best efforts to kind of mitigate functional unblinding.

Uh, there was also, um, you know, a publication.

Was it in NEJM, or was it...

It was in a medical journal that basically, uh, in the past few days that, um, you know, came from Dr. Davis and just like reiterates the same sort of perspective.

So, I mean, it's an interesting time, right? Because Compass is about to complete their NDA, um, in the fourth quarter.

Uh, it's a rolling review.

Um, you know, I think-- A-and it's also interesting 'cause I do think on the investor side, like we've still been getting questions a little bit on like, you know, could there be ad comms here? Could there be still lingering questions around things like functional unblinding, right? Like, you know, uh, like for Definium, you know, there's been this conversation around their next trial, and one of the doses is a, is a lower dose, and how subtherapeutic is it going to be, and how much does that matter? I, I think big picture, uh, clearly, like if not already, uh, we have leadership at the FDA who like appreciates the unmet need in psychiatry and is like very enthusiastic about this class of drugs.

And the battle between Cureleaf and Aurora Cannabis, well, it continues to get even more hostile.

On the psychedelic front, what a week it was for Compass Pathways, who delivered another significant update from its Phase 3 program.

So lots to get into here in our latest Trade to Black Weekly Recap presented by Free.

So let's get into it.

So that is some interesting news.

Finally, let's now move to psychedelics.

And the big one this week, Compass Pathways, released its 52-week results from Part C of its Phase 3 COMP005 trial involving COMP360 for treatment-resisted depression.

And here's what the data included.

But I think that it gets conflated a lot.

And we see this with like psilocybin mushrooms and psilocybin, where the push to federally legalize psilocybin, which may happen this year and the next with Compass Pathways, that's quite different, that product, than a psilocybin mushroom for a lot of reasons.

And I think there's a similar parallel in play with iboga versus ibogaine.

So I also want to ask another question about the Bweedy, but maybe we can sort of drill in a little bit on defining iboga versus ibogaine and i believe it's mainly ibogaine which is being looked at in the executive order and name dropped and expedited maybe at the federal level and then i think colorado just passed regulations for iboga so i and i've already been offered which i haven't taken up uh people trying to sell me Iboga, right.

There's just a lot of options, open interest at that 5 level, and you know what the market makers are going to do.

And don't look now, but Compass Pathways, what a day it was.

What did they get in volume? $7.7 million.

And that thing woke up.

So it's both, right? So you can have clinical trials after FDA approval, right? We have so many clinical trials related to depression treatments, both for medications and those for not.

But I think a lot of these from different... industries from like Compass Pathways, this one I've worked with before, just focused on psychedelic clinical trials, has focused on like, we need to do these kind of trials to see how efficacious it is for FDA approval.

So some of them are specific.

For like, we got to do these phased trials in order to show that this is efficacious.

Good way to wrap up.

Compass Pathways, that's ticker C-M-P-S, currently gaining about 3.9% post market, and that's after Bloomberg reports that the FDA is planning to tap Mike Davis to remain in charge of CDER, which is a really important branch of the FDA that oversees the safety, quality, and effectiveness of drugs.

And considering Compass is actually in the lead for potentially getting the first psychedelic treatment approved, it's definitely something that we're gonna be keeping an eye on and is moving that stock.

We've talked to Kabir Nath a lot.