Compass Pathways PLC

Yeah.

Uh, what a day for compass pathways too.

What were they down? They down 30% down 32% of the law based on way

off.

But so there could be some overlap between both drugs and I don't know, at the end of the day, I wouldn't jump to conclusions.

I think again, I'm not giving any investment advice.

I am a shareholder of compass pathways and, uh, we'll see how 2027 kind of unfolds, but it doesn't take away obviously the research they've done with their trials.

So, um, I looked at that and I just couldn't believe how much they were down, but it is what it is and we'll see how it goes.

We also share our analysis of over 600 public comments that landed on the FDA's psychedelics docket.

We look at how ISA, the healthcare cost-effectiveness watchdog of sorts, is set to review Compass Pathways' psilocybin for treatment-resistant depression package.

And we share some more takeaways from our psychedelic healthcare forum that we hosted with Horizons in New York City last month before diving into some other stories.

So let's get into it.

At least that's what we understand, according to sources close to the matter who spoke to psychedelic alpha on condition of anonymity.

That would make it the second psychedelic NDA under review at present by FDA, after Resilient Pharmaceuticals, which was formerly Lycos Therapeutics and before that MAPS PBC, refiled its MDMA for PTSD application in the summer.

Like Compass Pathways, a for-profit psilocybin drug developer, USONA holds a Commissioner's National Priority Voucher, CNPV, which aims to see the FDA make a decision within a couple of months after accepting the filing.

So if the most optimistic timelines hold, there could be a decision in the coming weeks and certainly months.

I mean, we've been working on it with Mac and Max.

At the back there, we've been talking about what a company called Compass is doing with psilocybin, which Mesoamerican cultures have been using for thousands of years.

And now Compass has basically patented a kind of polymorphic form, which is a crystal form of the underlying substance.

And now they're going to be charging $22,000 for a pill, is what's predicted.

And that's their intellectual property.

There was a bit of a joke at the time that you never wanted Annalisa to land in to chair your board as a CEO, because, you know, obviously I was getting the reputation for transitioning CEOs.

She has held around 50 board and trustee roles across biotech, venture capital, public bodies and medical charities, including Compass Pathways, AvroBio, Afomed and Moreo Biopharma, advised the FDA as a member of its science board and today chairs Ori Biotech.

You can't see scientific failure as a mark of personal failure.

Because actually, if you talk to the veterans of our industry, they all have stories.

And this has been a hot button issue that's come up, and I know there are different thoughts on this.

Compass famously started with therapy and then pivoted away from therapy.

And frankly, also is part of the FDA's comments and comments from advisors at the Lycos Advisory Committee meeting.

I think it actually scared some of the some of the drug development companies maybe away from psychotherapy.

The FDA has held out very strongly that we should know more about the importance of psychotherapy.

Is it dependent on a particular type of psychotherapy? Is it dependent on a particular amount of psychotherapy? Or is it all about the drug, right? And that's been a challenge for commercial developers, notably MAPS Lycos.

And now Compass has dealt with it, as you said, by just trying to dial down the psychotherapy to the bare minimum.

It's a place where we don't have data.

I mean, you kind of have to follow the science, you know, to answer that question.

And you have to look at these studies and, you know, Compass Pathways has gotten through their, you know, phase three clinical study, and they've got their synthetic psilocybin that's been submitted to the FDA.

I mean, clearly, you know, Trump was clear when he signed that executive order that he wants to fast track some kind of legalization.

So I guess the question is, Will the FDA throw him a bone? It seems to be if they wanted to do that, they've got that Compass Pathways submission sitting right there for them.

So I think that's fueling a lot of the rumors that are saying that legalization is coming at the end of this year or the beginning of next year.

MAPS, Lycos, whatever the new name of it is, has resubmitted their MDMA for PTSD.

And, um,

it seems really interesting.

The second looks at a preliminary sort of Ibogaine trial design floated by FDA, which has also asked for input on the topic.

We then look at Compass Pathways, which is talking pricing of its psilocybin candidate, potential labeling, and its plans for a relatively slow rollout.

We then look at New Mexico, which is nearing the launch of its medical psilocybin system.

And lastly, we look at six potential psychedelic brand names, at least according to trademark filings, before getting into some other headlines.

And this request for information moves that conversation into a more open forum rather than restricting those conversations to bilateral meetings between sponsors or investigators and the agency.

That request for information is now open through November 20th.

As it gets closer to a potential approval, Compass Pathways, the psilocybin drug developer, has been sharing more about its launch plans, mostly at investor events over the past month or so.

In terms of a progress update, it plans to submit the final parts of its new drug application to FDA this quarter.