▲ 64 r/DTIC

H.R.9559 - To accelerate the development of, and access to, psychedelic drugs that could save lives and reverse the crisis of serious mental illness in the United States, and for other purposes.

Bipartisan Congressional Bill Would Codify Trump’s Psychedelics Order Into Law

https://www.marijuanamoment.net/bipartisan-congressional-bill-would-codify-trumps-psychedelics-order-into-law/

H.R.9559 - To accelerate the development of, and access to, psychedelic drugs that could save lives and reverse the crisis of serious mental illness in the United States, and for other purposes. 

https://www.congress.gov/bill/119th-congress/house-bill/9559

Helps with DEA rescheduling visibility, manufacturing quotas, controlled distribution, clinical site expansion, VA-related treatment pathways, and broader institutional comfort around psychedelic medicine.

This is also the kind of policy shift that big pharma pays attention to. A late-stage drug with strong data is one thing. A late-stage drug with improving federal policy, potential priority voucher support, and clearer post-approval scheduling rules is much easier to underwrite.

Bullish for the whole sector.

congress.gov
u/twiggs462 — 4 days ago
▲ 75 r/DTIC

DFTX Current Job Listing Overview of Preparing for Commercial Success

This hiring slate is bullish as a launch-readiness signal, having like a company that believes DT120 has moved from “clinical asset” to “potential commercial product.”

https://job-boards.greenhouse.io/definiumtherapeutics

The jobs are not just trial-support roles. They are weighted toward pre-commercial launch infrastructure: HCP marketing, patient/digital marketing, sales leadership, product communications, MSLs, field VEOR, biostatistics/statistical programming, drug product development, and commercial supply chain. That is the exact mix you would expect when a late-stage biotech is preparing for NDA filing, label strategy, payer engagement, REMS/site-of-care planning, and possible commercial launch**.

This is not random hiring. It breaks into a very clear late-stage biotech playbook.

1. Commercial launch buildout

These roles are the loudest signal:

  • Vice President, Sales
  • Senior Product Manager, HCP Marketing
  • Director, Patient & Digital Marketing
  • Associate Director, Medical Marketing
  • Director, Product Communications

That is classic pre-launch commercialization. A company does not usually build HCP marketing, patient digital, sales leadership, and product communications unless it is actively preparing the market. This does not mean approval is guaranteed, but it does mean management is preparing for the possibility that the clinical package supports filing and launch.

For DT120, this matters because the product is not a simple “ship pills to CVS” launch. It likely requires physician education, patient screening, dosing-session logistics, payer/reimbursement preparation, and potentially REMS-style controls. The Analyst Day deck already shows a support model with **field sales, medical support, access support, site-of-care support, HUB model, REMS, affordability support, benefits investigation, prior authorization support, case management, and trade/distribution.

So when you see DFTX hiring marketing, sales, communications, VEOR, MSLs, and supply chain, that lines up almost perfectly with the infrastructure shown in their commercial strategy.

2. Medical Affairs / MSL buildout

  • Senior MSL - East
  • Senior MSL - West

This is very important. Medical Science Liaisons are usually hired before launch to engage KOLs, educate investigators and treatment centers, handle scientific exchange, prepare congress strategy, and support evidence generation. In psychiatry — especially with a psychedelic-derived Schedule I compound — this is not optional. The field needs education.

MSLs also help bridge the gap between clinical data and real-world implementation. For DT120, they will need to explain:

DT120’s single-dose model, durability claims, safety/tolerability profile, absence of required psychotherapy in the trial design, dosing-session monitoring, potential REMS logistics, and how GAD/MDD populations were studied.

That is a strong launch-prep signal.

3. VEOR / payer strategy

  • Senior Director, Field VEOR

This might be one of the most bullish roles on the list.

VEOR means **Value, Evidence, and Outcomes Research**. This is where the company builds the payer-facing case: burden of disease, treatment failures, cost offsets, claims analyses, real-world outcomes, budget impact, and formulary value proposition.

The Analyst Day deck already shows that DFTX is thinking in payer terms: 4.2 million patients failed by 2+ prescriptions, potential revenue per 1% penetration, Spravato as a reimbursement analog, payer expectations of coverage for FDA-approved psychedelic treatments, and likely prior authorization management.

Hiring Field VEOR says: they are preparing for payer conversations, not just FDA conversations.

That is usually a later-stage move.

4. Biostatistics and statistical programming

  • Associate Director, Biostatistics
  • Senior Director, Biostatistics
  • Director, Statistical Programming

This is approval-path infrastructure. These are the people needed for Phase 3 readouts, integrated safety/efficacy analyses, FDA questions, NDA datasets, tables/listings/figures, subgroup analyses, label discussions, and post-hoc/pooled analyses.

For a company with multiple Phase 3 studies reading out close together, this is critical. DFTX’s decks show Emerge, Voyage, Panorama, Ascend, and future PTSD/Haven planning. They also emphasize SSRE, powering assumptions, minimum detectable differences, and integrated Phase 3 design logic.

This hiring tells me they are preparing for a heavy data package and possible regulatory submission work.

5. CMC / drug product / supply chain

  • Associate Director, Drug Product Development
  • Executive Director, Commercial Supply Chain

This is another major signal.

For DT120, commercial supply chain is not trivial. The asset is lysergide tartrate, a controlled substance. The company would need manufacturing, quality systems, controlled-substance handling, packaging, distribution, inventory controls, and potentially REMS-aligned logistics.

A commercial supply chain executive is not usually a “maybe someday” hire. It is a “we need to be ready if/when the product gets approved” hire.

This is especially relevant because DFTX is trying to create a scalable episodic-care model: single oral dose, 5–8 hour monitoring, end-of-session checklist, next-day return to normal activities, and treatment-site workflow. The May deck lays out that target product profile directly.

6. Clinical development and program management

  • Associate Director, Clinical Development
  • Senior Director, Clinical Development
  • Senior Project Manager

This supports ongoing trials, label expansion, extension studies, additional indications, FDA interactions, site oversight, and cross-functional execution. This is not as directly “commercial” as VP Sales or Field VEOR, but it supports the broader DT120 lifecycle.

The decks show DT120 is not just one trial in one indication. It is a platform-like clinical program across GAD, MDD, PTSD, and possible additional indications.

The biotech late-stage hiring playbook

A late-stage biotech usually evolves in stages:

Stage 1: Clinical proof-of-concept company

Mostly R&D, clinical operations, regulatory, CMC, finance. Commercial is small or nonexistent.

Stage 2: Pivotal-readout company

Adds biostatistics, statistical programming, regulatory ops, medical affairs planning, publication planning, market research, HEOR/VEOR, and early brand strategy.

Stage 3: Pre-NDA / pre-launch company

Adds HCP marketing, patient marketing, product communications, sales leadership, market access, field medical, commercial analytics, supply chain, patient services, HUB planning, distribution, and REMS planning.

Stage 4: Launch company

Adds field sales managers, reps, access/reimbursement teams, nurse educators/site support, patient services, pharmacovigilance expansion, trade/distribution, compliance, training, sales ops, and full medical affairs coverage.

DFTX’s job list looks like Stage 3. They are not merely keeping trials alive. They are building the bridge from Phase 3 data to market entry.

reddit.com
u/twiggs462 — 6 days ago
▲ 54 r/DTIC

DFTX Russell Reconstitution Update

Some people may see the MarketScreener headlines saying Definium Therapeutics was “dropped” from the Russell Microcap Index and Russell 3000 Value Benchmark.

The important part is that Definium was listed as a Russell Microcap deletion. That is actually a sign of the company’s growth. DFTX has moved far beyond the microcap stage. With the market cap now around the $5B area, this is no longer being treated like a tiny speculative biotech. It is moving into a larger market-cap category.

Russell style indexes are formula-based. Companies are reclassified between value, growth, or blended style exposure based on valuation and growth characteristics during reconstitution. A clinical-stage biotech that has rapidly appreciated after major Phase 3 progress is naturally going to look less like a traditional “value” name and more like a growth/innovation story.

DFTX is graduating out of microcap territory. Another sign that DFTX is evolving from a niche psychedelic biotech into a much more visible CNS platform company.

Sources:

https://www.marketscreener.com/news/definium-therapeutics-inc-nasdaqgs-dftx-dropped-from-russell-3000-value-benchmark-ce7f5fdeda8cf422

https://www.marketscreener.com/news/definium-therapeutics-inc-nasdaqgs-dftx-dropped-from-russell-microcap-index-ce7f5fdeda80ff21

https://www.lseg.com/content/dam/ftse-russell/en_us/documents/other/rmicro-deletions-20260626.pdf

u/twiggs462 — 7 days ago
▲ 92 r/DTIC

Post Phase 3 Results and Raise Clarity

I think this week may end up being one of the most important moments the psychedelic medicine sector has had so far.

Definium just delivered positive Phase 3 data in major depressive disorder for DT120, and I don’t think people are fully appreciating what that means yet.

The Emerge study met the primary endpoint and all key secondary endpoints. The headline number was an 8.1-point placebo-adjusted improvement on MADRS at Week 6, with p<0.0001. They also showed a 7.3-point placebo-adjusted improvement at Week 12, again with p<0.0001. For a single-dose treatment in depression, that is a serious result.

This matters because the biggest question in this sector has always been whether the Phase 2 signals would survive Phase 3. It is one thing to believe in the mechanism. It is another thing to see a psychedelic-derived medicine actually clear a late-stage, randomized, placebo-controlled trial in a major psychiatric indication. Definium has now done that, at least once.

Before this, the bull case was mostly built around potential: strong GAD Phase 2b data, a differentiated LSD-based mechanism, and the possibility that DT120 could become a broader psychiatry platform. Now the company has a positive Phase 3 result in MDD. That does not guarantee FDA approval, and it does not eliminate the need for more data, but it materially de-risks the program.

The stock reaction reflected that. The market did not treat this like a minor update. The stock gapped up hard, traded with real volume, and even after the offering announcement, it has held up surprisingly well. That part is important. Biotech offerings after a big data move can easily crush momentum if investors think the raise is desperate or poorly timed. In this case, the offering priced at $34, and the stock has traded well above that level afterward. To me, that suggests the market is absorbing the dilution and treating the raise as a strategic financing rather than a rescue financing.

The $700M offering is dilution. There is no point pretending otherwise. But not all dilution is equal. Raising money after a failed trial or into a weak stock is bad dilution. Raising $700M after a major Phase 3 win, while demand is strong, is a completely different situation. That is how a biotech strengthens its balance sheet from a position of leverage.
Definium already had a few hundred million in cash before this raise. Adding another $700M gives them a serious war chest. That money can fund additional Phase 3 work, regulatory preparation, commercial planning, market access work, manufacturing, treatment-site readiness, payer studies, and launch infrastructure if DT120 is approved. It also gives the company negotiating power.
That last point is important. A large cash pile does not just fund commercialization. It also changes the strategic posture of the company. If a potential partner or acquirer comes knocking, Definium does not have to negotiate from weakness. They can credibly say, “We have the data, we have the cash, and we can continue alone.”

Could Definium be acquired before FDA approval? I think it is possible. Not guaranteed, but possible. CNS assets with large market potential can get acquired pre-approval if the data are strong enough. The obvious comparison is Karuna, which was acquired by Bristol Myers before FDA approval of KarXT. That does not mean Definium gets the same outcome, but it does prove that big pharma will pay for de-risked psychiatry assets before approval when the commercial opportunity is large enough.

And that brings me to the broader industry.

I do not think this is a one-winner market. The “LSD versus psilocybin” debate is too simplistic. We are seeing a lot of this banter on r/shroomstocks - Psychiatry has never worked like that. SSRIs, SNRIs, atypical antidepressants, antipsychotic augmentation, ketamine/esketamine, TMS, ECT, talk therapy, and other approaches all coexist because depression and anxiety are not one disease with one solution. Different patients respond to different mechanisms. Different severity levels require different tools. Different providers and payors will prefer different models.

Compass can succeed with psilocybin. Definium can succeed with LSD. Atai can still have a role. Others may find specific niches. There does not need to be only one winner.

What matters is whether each treatment can prove efficacy, durability, safety, and a realistic commercial model. Definium just took a major step on the efficacy and durability side. The safety data, at least from the topline release, also look manageable. The big remaining debate is commercialization: monitoring time, reimbursement, provider logistics, REMS, and whether payors will support a longer interventional psychiatry session.

Those concerns are real, but I think some bears are looking at the issue too narrowly. A six-to-eight-hour treatment day sounds difficult if you compare it to a normal office visit. But that is not the right comparison. The right comparison is years of failed antidepressant cycling, chronic medication burden, disability, relapse, psychiatric visits, emergency care, and repeated treatments with other interventional options.

If a single supervised dose can produce meaningful improvement for weeks or months, payors will at least have to look at the health-economic argument. They may push back. They may restrict use. They may require prior authorizations. But if the clinical effect is strong enough and durable enough, the value proposition becomes very different than “expensive drug with inconvenient monitoring.”

Spravato already proved that monitored interventional psychiatry can exist commercially. It is not perfect, and DT120 would have a different treatment model, but the idea that payors and clinics will never support any monitored psychiatric treatment is already outdated. The question is not whether the model is easy. The question is whether the benefit is large enough to justify the friction. After this Phase 3 result, Definium has a much stronger argument that it may be.

The other major thing I like is the potential breadth of DT120. This is not just an MDD story. The company already had strong GAD Phase 2b results, and GAD is still a major upcoming catalyst. If GAD Phase 3 hits after this MDD result, the narrative changes again. Then DT120 starts looking less like a single-indication drug and more like a broad psychiatric platform: depression, anxiety, possibly PTSD, and maybe other neuropsychiatric conditions over time.

That is why I think this week matters for the entire sector. A clean Phase 3 win gives legitimacy not just to Definium, but to the broader idea that psychedelic-derived medicines can be developed through normal FDA pathways. The sector needed real late-stage validation. This is exactly the kind of validation investors, regulators, payors, and potential pharma partners needed to see.

There will still be volatility. There will be dilution debates. There will be people arguing over discharge timing, monitoring requirements, trial population, REMS, and whether MDD is the right initial market. That is fine. Those are fair debates. But none of that changes the fact that a Phase 3 trial just hit with a large placebo-adjusted effect and durability through Week 12. That is the kind of result that changes assumptions.

For me, the $700M raise is not a negative signal. It looks like a company taking advantage of a major de-risking event to fund the next stage of the business. That could mean preparing to commercialize. It could mean strengthening the balance sheet before partnership talks. It could mean making sure they are not forced into a cheap acquisition. It could mean all of the above.

I would much rather see a biotech raise from strength after positive Phase 3 data than wait until they are desperate. Definium is now in a much stronger position than it was before this readout. DT120 is no longer just a speculative psychedelic asset. It has late-stage data in a major psychiatric indication, a large cash position, multiple upcoming catalysts, and a realistic path toward becoming one of the first major psychedelic-derived psychiatric medicines to reach the market.

There is still risk. There is always risk in biotech. They still need more data, FDA alignment, and a workable commercial model. But the risk/reward changed meaningfully with this result.

I do not think the sector needed perfection this week. It needed proof that these drugs can work in Phase 3.
Definium just gave us that proof.

And with that... I wish all you luck. Even the naysayers, but mostly the believers in this sector and not those trying to nitpick the finer points. We are in the final stretch. Be glad you are here.

reddit.com
u/twiggs462 — 11 days ago
▲ 2 r/neuro+1 crossposts

Definium Therapeutics Announces Positive Topline Results from Phase 3 Emerge Study of DT120 Orally Disintegrating Tablet (ODT) in Major Depressive Disorder

Study met primary and all key secondary efficacy endpoints
8.1 point Montgomery-Åsberg Depression Rating Scale (MADRS) placebo-adjusted change from baseline at Week 6 for the primary endpoint (p<0.0001)
7.3 point MADRS placebo-adjusted change from baseline at Week 12, a secondary endpoint (p<0.0001)
DT120 ODT was generally well tolerated with no serious adverse events or suicidality signal

ir.definiumtx.com
u/twiggs462 — 14 days ago

Definium Therapeutics Announces Positive Topline Results from Phase 3 Emerge Study of DT120 Orally Disintegrating Tablet (ODT) in Major Depressive Disorder

Definium Therapeutics Announces Positive Topline Results from Phase 3 Emerge Study of DT120 Orally Disintegrating Tablet (ODT) in Major Depressive Disorder

https://ir.definiumtx.com/news-events/press-releases/detail/232/definium-therapeutics-announces-positive-topline-results-from-phase-3-emerge-study-of-dt120-orally-disintegrating-tablet-odt-in-major-depressive-disorder

Study met primary and all key secondary efficacy endpoints
8.1 point Montgomery-Åsberg Depression Rating Scale (MADRS) placebo-adjusted change from baseline at Week 6 for the primary endpoint (p<0.0001)
7.3 point MADRS placebo-adjusted change from baseline at Week 12, a secondary endpoint (p<0.0001)
DT120 ODT was generally well tolerated with no serious adverse events or suicidality signal

u/twiggs462 — 14 days ago
▲ 22 r/DTIC

Acute and post-acute neurobehavioral responses to lysergic acid diethylamide in healthy subjects: a randomized controlled study

nature.com
u/twiggs462 — 17 days ago

How do you pull these tabs back into the slot for the Thule Cross Bars?

I purchased the Thule Rapid System Subaru extended crossbar set. SOA567X070.

I have a Subaru outback wilderness 2026. I've installed crossbars on other cars but these things are pretty damn tight to pull. I thought I loosen them but any tips on getting these attached properly?

u/twiggs462 — 19 days ago

Better Sex, Better Hair, Better Sleep: ‘Humanmaxxing’ Is Here - New York Times

The biotech billionaire who wants to rebuild your body and blow your mind.

nytimes.com
u/twiggs462 — 25 days ago
▲ 55 r/DTIC+1 crossposts

Drugs that change your mind are about to hit the market

Owner, CBT Advisors

May 28, 2026

Cambridge, MA, May 28, 2026

In just a few months, LSD and psilocybin, the active ingredient in “magic mushrooms,” will approach the market. Biotech companies developing pharmaceutical versions of these substances are expecting Phase 3 trial readouts in the next few months and, soon after that, physicians will likely be prescribing them to patients with conditions such as generalized anxiety disorder (GAD) and major depressive disorder (MDD). In the United States, generalized anxiety disorder affects roughly 3 to 7% of adults in a given year (on the order of 7 to 15 million people).[1] Major depressive disorder affects well over 10% of US adults.[2] Behind those large-market indications are other significant ones like post-traumatic stress disorder (4%)[3] and substance abuse (16%).[4]

The efficacy of the psychedelic-based drug candidates in Phase 2 clinical trials has been remarkable, showing full remissions for the LSD-based product DT120 in development by Definium Therapeutics (formerly MindMed) in up to 48 per cent of anxiety disorder patients in the optimal dose arm, even when these patients had previously been plagued with severe anxiety. The developers believe, based on the statistically significant results reported in an investigator-initiated trial conducted in MDD with a similar LSD-like molecule, that comparable outcomes might also be achieved in MDD.

There is much that I love about this stunning turn of events:

  • The astonishing success rates the drugs have had in tough-to-treat disorders;
  • the companies overcoming regulatory and logistical challenges to bring them closer to the market; and
  • the delightful unexpectedness of drugs formerly associated with the 1960s counterculture and recreational “trips” becoming a major part of psychiatrists’ arsenals offering the potential to improve health and well-being.

I chaired a panel at a recent life sciences conference, Convergence Forum on Cape Cod, where we heard from three leaders in neuropsychiatric drug discovery working with psychedelics and related drug candidates. Drawing from their comments and my own research, here is how I believe this trend will play out to both patients’ and society’s benefit.

I suggest that, similar to the seismic effect on society of GLP-1s, widespread legal use of psychedelic therapies will impact many more patients than initially being addressed. Furthermore, all of us, not just patients, may well be directly or indirectly impacted. Why am I so convinced of this? Because the drug candidates are:

  • Mysterious: These drug candidates are both highly efficacious and also somewhat mysterious in their mechanism of action. Once on the market, their use is likely to drive greater understanding of how the brain works.
  • Differentiated: The candidates are different from any drugs on the market. This includes the ketamine derivative Spravato® from Janssen Pharmaceuticals, a nearly $2 billion drug more limited in its utility and its upside than LSD-based or psilocybin-based drugs are likely to be.
  • Likely to be prescribed widely, also off-label: Psychedelics are likely to be prescribed both on-label for anxiety and depression and, eventually, off-label for a wide variety of other ailments.
  • Inspiring to the point of evangelism: Finally, because, once approved and used, they will result in a growing cohort of evangelizing patients talking about their treatment in reverent, even quasi-religious terms

Due to all these factors, I believe that the launch of the first few psychedelic therapies will represent a turning point in the history of the industry and perhaps a bigger one for the rest of us.

Mystery: A Teachable Moment for Neuroscientists

LSD, psilocybin and their psychedelic cousins have been glorified and vilified for decades for their mind-altering powers. But despite the fact that drugs based on these compounds are on the verge of regulatory approval, we still do not know how they work. As panelist Dan Karlin, a practicing psychiatrist and the Chief Medical Officer of Definium Therapeutics, put it, “LSD is an incredibly potent drug. Whether its mechanism is mediated to some extent by the experience, to some extent by downstream signaling and direct drug effects, you don't know the answer to that. We don't really know what's mediating what, and it's not a binary. Nothing in psychiatry, nothing in medicine, is a binary. So at the end of the day, it's not, is it mediated by one or the other? It's which bits of it are mediated by what? But regardless, we do have this really dramatic period of altered consciousness.”

Surprising as this might sound, it is not so different in some ways from aspirin, which, like psilocybin and LSD derivatives, is another synthetic version of a natural product that happened to hit the market in 1899. Expect a wave of scientific discoveries based on post-marketing studies, imaging studies and clinical observations.

Differentiation: Drugs That Bring Novel Benefits Can Earn Outsized Revenues

Primarily because their effect size is so much larger than that of all approved drugs, they are expected to have great commercial success. Panelist Bruce Leuchter, M.D. is CEO of Neurvati Neurosciences, a Blackstone company, and also a practicing psychiatrist. He emphasizes that the drugs modulate the monoamine oxidase enzyme, biology that is understood in terms of other candidates, but that the size of the effect is differentiated. Leuchter said that the members of the first wave of approved psychedelic therapies (assuming positive data and reasonable reimbursement), have potential multibillion-dollar peak sales, with a few variables driving the numbers up or down:

  • How broadly can they be prescribed? Can they treat GAD and MDD alone or can they also expand into other indications like PTSD?
  • How durable will their effect be? Can they be “one and done”? (If so, this would limit their commercial attractiveness.)
  • How scalable is the delivery model? That is, how easily can companies get their products to patients, especially if patients have to be treated under supervision? This could become a key issue.
  • How flexible will the drug label be, e.g. does it allow for only use as a monotherapy or can it also be used in conjunction with other therapies? Will the potentially powerful effects of these drugs limit their use to supervised or on-label settings?

Importantly, he cautioned, these revenue projections assume that operational constraints—clinic capacity, trained personnel, and payer logistics—are at least partially solved. If a drug company can truly scale its psychedelic sales, he said, there is upside beyond that range. The most “fragile” variables, Leuchter added, are not science or efficacy – those risks are lower now – but rather the delivery risk and the economic risk, which he believes remain underappreciated.

Likely to be Widely Prescribed, Potentially Also Off-Label

Once safety is established in a commercial setting, an admittedly non-trivial hurdle, there are few limits on the indications in which psychedelics, once approved and commercially available, might get tried. For example, cancer: In Michael Pollan’s groundbreaking 2018 book How to Change Your Mind, the psychedelics pioneer Roland Griffiths of Johns Hopkins University cited a study that "found one of the largest treatment effects ever demonstrated for a psychiatric intervention." It reported that the majority of volunteers - all of them cancer patients - who had a mystical experience e.g. induced by psilocybin "reported that their fear of death had either greatly diminished or completely disappeared." [5] This is just one admittedly dramatic example of how approved psilocybin-based and LSD-based drugs might find their way to more patients.

Evangelism: Landing on Fertile Ground

I believe that news of effective psychedelics starting to be used in the initial indications will trigger news coverage and anecdotal reports and hence much wider interest. The initial indications targeted by Definium, generalized anxiety disorder, and by Compass Pathways, treatment-resistant depression, are just the beginning. The ground has been prepared for strong uptake for these drugs based on the decline in the only truly effective alternative for most patients, months or years of talk therapy. While talk therapy is demonstrably effective, it is neither readily reimbursed nor affordable out-of-pocket for most patients. As Karlin put it, “Because of mechanisms of payment, in essence, psychiatry, when it is insurance-supported, has been reduced to only being able to make money through short medical management visits.” Consequently, the need for effective interventions is greater than ever. Definium and other companies have designed their clinical studies accordingly, so that patients are not required to see a psychotherapist for talk therapy in order to be eligible. Indeed, the need for supervised dosing of these drugs, which will be mandated at least initially and perhaps permanently given their powerful effects, can be met by an infrastructure that has already sprung up in response to the approval of Spravato, a ketamine derivative dosed as a nasal spray and prescribed for depression. Spravato, which is considered “dissociative” rather than psychedelic in nature, is generating projected annual revenues of $1.7 billion as of mid-2025.[6]

The ketamine clinics that sprang up to deliver Spravato are a perfect example of what may happen when LSD- and psilocybin-based drugs are approved. When Janssen Pharmaceuticals, a division of Johnson & Johnson, launched Spravato in 2019, Karlin said, “They were aiming at delivering it in emergency rooms and inpatient units. They hadn't even contemplated a world where this could be an outpatient treatment, yet that world came into being because of the existence of the drug.”

Leuchter concurred that there is a vast opportunity for these therapeutics: “Irrespective of regulatory dynamics, irrespective of commercial dynamics, there's a space for anything that can generate this kind of effect size. And it's so obvious when you see it, which is also so atypical for neuroscience. So there are so many things about this space that sort of defy gravity.”

Taking the fun out of the fungi: psychedelics without the trips

As to the future of psychedelics, besides robust uptake of the drugs in this category, there is likely to be an actual broadening of the category itself to encompass drugs that, as panelist Mark Rus put it, “take the fun out of the fungi.” Rus is CEO of Delix Therapeutics, which is working on a category of drugs that is intended to deliver LSD-like or psilocybin-like efficacy but not to trigger a psychedelic or dissociative experience. Delix has generated Phase 1b clinical trial data showing equivalent depression score drops for their lead candidate zalsupindole as compared to hallucinogenic first-generation drug candidates targeting the same receptor. Both Leuchter and Karlin warmly welcomed the development of these so-called “neuroplastogens,” which would conceivably both address lingering concerns about undesired effects of psychedelics and also broaden still further the range of indications that could be addressed with the drugs. Delix was recently granted the go-ahead from FDA to have patients take their pills home during early clinical trials and to take them without in-person medical supervision.

Pollan’s book drew from his prodigious research on a number of psychedelics, including LSD and psilocybin as well as some related drugs, each of which he dutifully consumed in order to properly research their effects and to anticipate how they would affect others. The book, while based in large part on his own experience, was nonetheless as thorough and sensitive a study as I have seen on the way these drugs work and how it feels to take them. Once these powerful new medicines are approved, we will, I believe, move from individuals “changing their minds” to society itself changing for the better, with an accompanying boost in mental health, in fresh thinking and in new insights into how the mind itself works.

NOTE: I invest broadly in the stocks of biotech companies including some of the ones mentioned in this piece.

[1] The prevalence and burden of generalized anxiety disorder in the United States healthcare system: Real-world prevalence and incidence from 2020 to 2023 - ScienceDirect

[2] National Health Statistics Reports, Number 213, November 4, 2024

[3] Important Facts and Statistics About PTSD (Post-Traumatic Stress Disorder)

[4] Alcohol and Drug Abuse Statistics (Facts About Addiction)

[5] Psilocybin produces substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer: A randomized double-blind trial - PubMed

[6] Spravato Sales Surge: J&J's Ketamine Nasal Spray Nears Blockbuster

linkedin.com
u/twiggs462 — 1 month ago
▲ 33 r/DTIC+1 crossposts

S.4220 - Veterans Health Administration Novel Therapeutics Preparedness Act

Congress finds the following:

(1) Emerging therapeutic interventions, including certain psychedelic-assisted therapies under evaluation by the Food and Drug Administration as of the date of the enactment of this Act, may significantly alter the treatment landscape for post-traumatic stress disorder, depression, and other mental health conditions affecting veterans.

(2) The administration of certain emerging therapies may require intensive clinical engagement, interdisciplinary teams, dedicated clinical space, structured preparation, and post-treatment integration that differ substantially from traditional outpatient mental health services.

(3) The Department of Veterans Affairs is uniquely positioned to deliver integrated, veteran-centered care that combines medical, mental health, and peer support services within a single system of care.

(4) Absent centralized governance and implementation planning, the Department may face delays, safety risks, or inconsistent access following regulatory approval of such therapies.

(5) Establishing a dedicated Office of Novel Therapeutics will ensure that the Department is prepared to responsibly evaluate, research, and implement emerging treatment modalities consistent with patient safety and evidence-based practice.

congress.gov
u/twiggs462 — 1 month ago
▲ 24 r/DTIC+1 crossposts

Where Psychedelic Treatments Fit in Modern Clinical Care

Key points

  • PAT may be best understood as a specialty mental health intervention embedded in collaborative care.
  • Referral pathways mirror a familiar primary-care-to-specialist model used across medicine and psychology.
  • PAT can help patients become more emotionally flexible and engaged in ongoing therapy.
  • Ideal integration depends on continuity, communication, and returning patients to their primary providers.
psychologytoday.com
u/twiggs462 — 1 month ago
▲ 53 r/DTIC+1 crossposts

DT-120 for Generalized Anxiety: Addressing the Gap With Optimized LSD Pharmacotherapy

Jessica Malberg, PhD, and Dan Karlin, MD, shared about DT-120, a pharmaceutically optimized formulation of LSD, and discussed the unmet need driving its development in generalized anxiety disorder and major depressive disorder.1 Karlin and Malberg provided an overview of the phase 2b efficacy data: a single dose of DT-120 produced a 7.7-point separation from placebo and achieved full clinical remission in 48% of patients with moderate to severe generalized anxiety disorder, with effects measured at 12 weeks post-dose.

psychiatrictimes.com
u/twiggs462 — 1 month ago
▲ 2 r/mac

I have a mint MacBook Pro 13" 2019 i5 Touchbar given to me. Is it even worth keeping?

I upgraded my mom to an M5 MacBook Air 24GB version. She doesn't want the old laptop. I can clean it off and use it but i know its quite slow. Is it work keeping for anything? If I can boot windows 10 directly on it I could use it as a auto diagnostic laptop maybe, but wnated some feedback on this one.

reddit.com
u/twiggs462 — 1 month ago