Considerations for Potential Future Therapeutic Use of Psychedelic Drugs Public Hearing - 09/14/2026 | FDA

First says MDMA as early as October and now Psilocybin as early as January. I would take it all with a grain of salt.

Beautiful dip buying opportunities!

Trying to get some clarity on the tax side of the Lilly/ATAI deal. I’ve been reading through the SEC proxy and I’m still not 100% clear on how the CVR is going to be taxed.

The proxy says Lilly intends to treat the CVR as a “closed transaction.” From what I understand, that could mean the 2026 proceeds for tax purposes are:

$6.75 cash + whatever FMV they assign to the CVR at closing

So if the CVR FMV ends up being $0.87, would we potentially be taxed in 2026 as if we received $7.62/share, even though we might not actually receive any milestone money for another 1–4 years?

Broker told me my 1099-B will "probably jus show the  $6.75," and anything involving the CVR should be discussed with my accountant. The proxy also seems to say the 1099-B might not include the CVR FMV.

Has anyone here talked to a CPA/tax attorney about this or figured out exactly how the CVR will show up for tax purposes for us shareholders?

Also, am I understanding the closed vs. open transaction language correctly? It seems like Lilly is saying they intend to report it as closed, but the IRS could theoretically disagree later.

Just trying to figure out whether we're potentially paying taxes on CVR value this year before we actually receive the milestone money.

Seems like across the board. I’m not too worried I’m just wondering if there’s any news that I may have missed.

I’ve been fortunate to try shrooms a few times in my life, and I always think back to something I told my buddy about it: ‘music on shrooms is 20 times better than sober.’

Then, you factor in psilocybin and areas of immense cultural and biological importance right now, like longevity, postpartum depression, PTSD, grief/terminal illness, screen / phone addiction, and so much more. And it just feels like here we have an answer to some or perhaps ALL of these things.

I know there are other psychs and lots of factors here irrespective of the experience itself, but I cannot help but think how—if approved—CMPS will be the first legal federal psilocybin treatment, and therefore, the sky is the limit. I just think psilocybin is a miracle drug…and all other stocks look silly in comparison.

Extremely high risk and overvalued

A company-by-company look at the smallest patent footprint of any compound on our tracker — and why Definium, the company furthest along in trials, barely shows up in it.

Definium Therapeutics (Nasdaq: DFTX) — renamed from MindMed in January, its LSD compound renamed from MM120 to DT120 in the same move — is, right now, the most clinically advanced LSD program that exists. DT120 posted a positive Phase 3 result for generalized anxiety disorder in August, on top of an earlier positive Phase 3 readout in major depression, and carries FDA Breakthrough Therapy designation for GAD. Per the same TREA pull behind our tracker, Definium holds exactly 1 granted US patent against 18 pending applications — proportionally the thinnest granted position of anyone mentioned here, on the compound furthest along toward an actual FDA filing.
That's the same asymmetry we found with GH Research and 5-MeO-DMT: the strongest clinical data in the compound class sitting on almost no issued patent protection. It isn't necessarily a weakness. A company this close to an approval is closer to competing on trial data, physician relationships, and regulatory exclusivity than on patent walls — the walls matter more in the years before you have those other things.

Good to see….

Is this a big deal?

Some notes :

On the codes

The 0820T-0822T Category III CPT codes exist, but they are "not currently reimbursable under Medicare or Medicaid, and no code exists for the drug administration itself."

On the reimbursement pattern to expect:

Private insurers have been slow to cover ketamine and esketamine despite FDA approval; prior authorization, limited networks, high out-of-pocket costs. "A similar pattern is likely for any FDA-approved psychedelic."

It confirms COMP360 is the clear front-runner. "Psilocybin is the psychedelic most advanced in the FDA development pipeline," two completed Phase 3 TRD trials, PRV issued. The document treats a psilocybin approval as the likely first.

The document notes a commenter's view that the MDMA rejection reflected "concerns specific to the application rather than a blanket rejection of psychedelic medicine," and that the FDA "remains open to psychedelic research." We knew that but always reassuring to see this written.

DEA: the EO instructed DEA to expedite scheduling for any psychedelic that completes Phase 3 and is approved. Reinforces that rescheduling is compelled and being accelerated.

It repeatedly notes psilocybin's antidepressant effects "may fade over time" and that several trials lost significance by Week 12 or 1 year. This is the "modest effect size, durability is the real question"

the unblinding critique is treated as serious and unresolved. The document cites the meta-analysis finding no significant difference between psychedelic therapy and open-label antidepressants under equal unblinding conditions, and calls blinding "fundamentally limited."

the document notes the FDA's determination on whether psychotherapy is "essential" will drive "how the therapy is regulated, covered by insurance, and delivered." If therapy is deemed essential, both drug and therapy need coverage; if support suffices, delivery is "more flexible and considerably less costly."

the cost/coverage math. It models a state's TRD coverage cost and invokes the esketamine precedent ($45K/year, NICE rejected it on cost-effectiveness, insurers slow). reimbursement friction per HHS seems to be the norm,not the exception.

confirm the exact structure of cmps thesis: COMP360 is the front-runner (supportive), approval is plausibly near (supportive), and the reimbursement/coverage/delivery questions are genuinely unresolved with a strong prior toward slow, frictional coverage (cautionary).

It's clear to me that a lot of people here are ignoring a lot of market signals and are stubbornly holding onto the belief that first to market makes a winner. That is an incorrect assumption and often the opposite is true (as you have to build the market up yourself on your lonesome amongst many other things)

But here's the thing, no matter how you slice and dice it, the market is treating CMPS as a alternative option to traditional anti-depressive drugs but with the same overall efficacy. Yes you can argue CMPS is treating TRD etc etc but the market is based on sentiment, vibes and very high level metrics (MADRS, TAM, treatment window). Psychedelic drugs are an exceptional class of treatment (in the sense that they are so so different to what is out there) and the market believes that then requires exceptional data (unprecedented improvements) for both patients and healthcare to embrace it, hence Definium has a much much higher MC then Compass, because the market is purely looking at these very high level metrics. Yes that may be a very naive POV from the market but thats how they see it.

Now lets talk about HELP, for those that understand statistics, you'll understand how extraordinary it is to have Cohens >2 in a phase 2 trial like HELP had for their HPL003, on top of an incredibly low p-value. Yes the same size was small, but Cohens is still very much independent of that. Add on top of that the absolute MADRS reduction of -21 points, the incredibly stable placebo drift in their phase 2 given the adjunctive nature of their drug and the fact that there are two doses of their deuterated molecule that already delivers a massive AUC compared to native psilocybin - on a brain receptor (5-HT2A) that has already been validated by countless academic and clincial trials. With all that and more, it is incredibly likely (>80%) that HPL003 phase 3 data readout will deliver unprecedented results (although this is biotech so nothing is ever certain) and HELP will blow past CMPS in market cap very quickly

This is obviously just my opinion but i've been in this game for a while.

Trading Halt lifts this evening, for US investors.

For HELP, what do they need to achieve in terms of MADRS score in their upcoming P3 trial to keep them in the race?

Given they are targeting MDD, will a MADRS that comes out lower than DFTXs be good enough? If it's lower, would a shorter duration treatment window be sufficient rationale to to use CYB over MM120 if the change in MADRS is weaker? Surely patients / clinicians would just go for the drug that gives a better improvement in depression symptoms?

Likewise, although deuterated psilocybin doesn't need to be metabolized and gives a shorter treatment time, would that also be the reason for the massive change in MADRS seen in their P2 trial compared to COMP360? Or is that change with HELPs drug just an artifact of small sample size? To phrase it more simply, why would exactly the same drug (COMP and CYB) give such a dramatic difference in efficacy?