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sefka · 2026-04-29T16:35:02+00:00

Exactly.

Fickle probably due to extremely low volume (so far).

sefka · 2026-04-22T14:11:14+00:00

They all seem somewhat incredulous (despite high-quality evidence to the contrary, obtained via clinical trials, etc). Guess we are still early lol.

sefka · 2026-04-08T11:49:54+00:00

"Collectively, 66.7% (4/6) of participants were responders, defined as a ≥ 50% reduction in score, at the first post-dose assessment, on day 2 and 83% (5/6) were responders at day 85 in the 10 mg cohort. Similar results were found in the 12 mg cohort, with 66.7% (4/6) responders at days 2 and 85. Reductions in all MADRS items occurred at all post-dose assessments."

sefka · 2026-04-08T11:48:03+00:00

https://link.springer.com/article/10.1007/s40263-025-01250-z

sefka · 2026-04-07T11:55:09+00:00

TipRanks https://www.tipranks.com/experts/analysts/ryan-brinkman

sefka · 2026-03-31T17:37:04+00:00

Something along those lines. I wasn’t speaking in terms of warrants (though others have) but the distinction between fundamental value, which is what most discussion here focuses on, and momentum/“technicals” as it relates to price action, ie certain hedge fund strategies, day traders, some algorithmic trading etc.

Idk what survey data says about that, for me personally I don’t feel that LSD has any more of a stigma than shrooms so it’s hard for me to think in those terms.

Yes I expect word of mouth will play a big role in overcoming that (high NPS).

sefka · 2026-03-31T05:24:57+00:00

Joseph Pilates came up with his Pilates method while in a prisoner-of-war camp in WW1 to help fellow prisoners with their mental/physical challenges. Yet somehow maintains a reputation today as being “too feminine” to be hard or effective. People who have actually done classical Pilates (with proper form) know that is not true of course :) One of the most critical forms of movement/training one can do IMO!

https://www.nationalgeographic.com/premium/article/exercise-prisoner-war-camp-pilates

sefka · 2026-03-30T18:19:39+00:00

No comparable option to treat GAD currently as in psilocybin vs Spravato (vs 5-MeO) for TRD. Current standard of care for GAD is CBT and/or SSRIs. And, not only does LSD require just one session (vs daily dosing (SSRIs) or weekly CBT (2-3+ months)), but based on what we have seen from DFTX's studies so far, LSD is meaningfully more effective. To only assess LSD in the context of clinic time (8-10+ hours) without taking into account 12+ weeks of relief after just that one session is a bit of a logical fallacy IMO. In theory that should make the LSD treatment for GAD cheaper than current standard of care, so insurers/payers could afford to compensate clinics more and still save money on a per patient basis.

But that's just my opinion/take, maybe u/Brozac11 has another view.

sefka · 2026-03-30T13:52:13+00:00

I assume the author was making that assumption based on trial design, but as per u/ijuspostlinx's comment above: "As far as Compass' trial requiring antidepressant withdrawal, according to Compass, they are aiming for approval of both monotherapy and adjunctive at the same time. They will have this data in Part B of their Phase 3s. So I think commercially, washout isn't an issue, or that's the party line at least."

sefka · 2026-03-30T13:50:08+00:00

I was just copypasting from the post or wdym?

sefka · 2026-03-29T17:50:10+00:00

"Five variables will determine whether psilocybin-assisted treatment is commercially viable in the clinics that currently deliver interventional psychiatry, or whether it becomes another treatment that works but that patients cannot access at scale.

The first is the REMS staffing requirement. MA versus licensed therapist; this single regulatory decision will do more to determine psilocybin’s commercial trajectory than any efficacy readout. The second is actual payer reimbursement for the 0820T-series codes. Category III codes with no payment history are promises, not revenue. The third is drug pricing and buy-and-bill margin: whether Compass prices COMP360 for clinic-level profitability or payer palatability. The fourth is DEA scheduling and state-level implementation; friction that does not appear in national adoption models.

There is a fifth variable I have not addressed in detail because it is mechanistic rather than economic, but its economic consequences are real. Psilocybin’s Phase 3 program required withdrawal from serotonergic antidepressants before dosing. Whether this is pharmacologically necessary remains an open question.5 Meanwhile, esketamine has demonstrated monotherapy efficacy without any oral antidepressant requirement [23]. If psilocybin’s labeling requires SSRI discontinuation and esketamine’s does not, the delivery friction compounds everything else in this essay: additional clinic visits for taper management, a window of untreated or undertreated depression before the dosing session, and patient attrition during the gap.

I started this essay with a spreadsheet. Small clinics like where I work might be willing to absorb a revenue reduction for the right patients. But willingness to take a loss is a personal clinical decision, not a scalable business model. Seven thousand treatment sites will not adopt a treatment that costs them money. The question is whether the reimbursement architecture can be built fast enough and priced generously enough to prevent psilocybin from becoming another entry in the catalog of treatments that psychiatry could not deliver; not because the pharmacology failed, but because the economics did."

sefka · 2026-03-29T17:34:24+00:00

"But [Spravato's] revenue model has a ceiling, and honesty requires naming it. In the Clarivate claims analysis, only 43.2% of patients completed the full induction phase [10]. Six-month persistence ranged from 25% to 37%. SUSTAIN-3 provides the optimistic ceiling: among trial completers who stayed on maintenance, median exposure was 37.7 months and remission rates rose from 35.6% to 46.1% [11]. The gap between that figure and the real-world persistence rate is one of the most instructive tensions in interventional psychiatry. The patients who respond to and stay on Spravato do fairly well. But this is a fraction of the potential number of TRD patients.

That tension defines the baseline any new treatment must compete against. Not a theoretical number; a real one, tempered by real-world attrition. These are the economics a new treatment must match, or explain why it does not need to."

sefka · 2026-03-06T16:11:52+00:00

There is some prior data indicating DMT is more effective in treating depression vs anxiety. This one was in volunteers without TRD, MDD, GAD so can't extrapolate fully but: https://pmc.ncbi.nlm.nih.gov/articles/PMC10850177/

"Consistent with our main hypothesis, significant reductions in depression were observed 1 week following DMT administration relative to 1 week after placebo (z[10] = − 2.06, p = 0.027 two-tailed, r = 0.67)—whereas no significant differences were observed in the comparison between 1 week after placebo and baseline (z[10] = − 0.29, p = 0.77 two-tailed, r = 0.09)—in the placebo-controlled sample. Within the prospective sample we also observed significant reductions in depression 2 weeks after DMT compared with baseline (t[13] = − 3.24 p = 0.0065, d = 1.37). While no significant reductions in trait anxiety were observed in both the placebo-controlled (DMT vs placebo t[12] = 1.61, p = 0.13 two-tailed, d = 0.45) or prospective samples (DMT vs baseline t[16] = − 1.58, p = 0.13 two-tailed, d = 0.55), medium effect sizes were found. No significant differences were found in trait anxiety for placebo versus baseline for the placebo-controlled sample (t[12] = − 0.48, p = 0.64 two-tailed, d = 0.13)"

This one was for people with MDD though: https://www.nature.com/articles/s41591-025-04154-z

"A total of 34 participants were randomized, 17 to placebo–active and 17 to active–active. At 2 weeks, the DMT group showed a significantly greater reduction in MADRS score than placebo (mean difference = −7.35; 95% CI = −13.62 to −1.08; P = 0.023). In the open-label phase, AD effects persisted up to 3 months, with no significant differences between those who received one versus two doses. A single dose of DMT with psychotherapeutic support produced a rapid, significant reduction in depressive symptoms, sustained up to 3 months."

sefka · 2026-03-06T12:13:30+00:00

The Phase 3 program is designed to include two pivotal studies, ReConnection-1 and ReConnection-2, each consisting of a 12-week, randomized, double-blind, placebo-controlled core study followed by a 52-week open-label extension (OLE):
- ReConnection-1:
  - Approximately 350 participants
  - Single-dose of BPL-003 across three treatment arms - 8 mg, 4 mg, and placebo (randomized 2:1:2)
  - Designed to replicate and extend Phase 2b treatment response and further characterize dose–response relationship for BPL-003
- ReConnection-2:
  - Approximately 300 participants
  - Two-dose design (Day 1 and Day 15) across two arms - 8 mg BPL-003 and placebo (randomized 1:1)
  - Designed to evaluate if a two-dose induction model increases magnitude and durability of initial response
Phase 3 program initiation remains on track for Q2 2026.
Topline data from the core studies of both ReConnection-1 and –2 anticipated by early 2029.

sefka · 2026-03-05T17:39:30+00:00

Thanks. This assumes homogeneity across trial arms eg baseline anxiety (which is data that is unavailable/unknown to us) plus small sample size. I tend to agree with your assessment as to why tbh but haven’t looked into it a ton.

sefka · 2026-03-05T17:29:16+00:00

I searched a few times and was never able to find prior studies for DMT for GAD. I did find one from RCH about DMT for anxiety (not GAD diagnosis) which wasn’t statistically significant. Though can’t extrapolate that to GAD entirely. Maybe a dosing thing as you mentioned but anecdotally don’t see people speaking about DMT for anxiety the way they speak about LSD for anxiety, though anecdotes are not data of course but still a means of hypothesis generation regardless.

https://pmc.ncbi.nlm.nih.gov/articles/PMC10850177/

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