I listened to the last couple of earnings calls. It doesn’t seem like it’s taking off quickly, even though there’s certainly a lot of future potential.
Regarding revenue, it seems that no rapid growth is expected in the very near future, because they are focusing on current OGM routine users to save cash, and according to Q3 2024, there is potential for slow revenue growth in that population, but no significant “overnight” growth. Costs have indeed been brought down significantly, but they will likely remain in the red for quite some time, and the cash reserves are quite thin.
Another thing that caught my attention was these warrants from before. There was one batch that entitles them to a few million in potential additional funding, and another, which I recall had a potential of 20 million. Together, these would already be roughly 200% compared to the current market capitalization, and the exercise price per share was tens of cents, not euros as the current share price is. So, if the business progresses, they would likely get the necessary additional funding from this, but the dilution would indeed be very significant!
By the way, have they expressed any plans for seeking FDA approval for clinical diagnostics? Or could clinical diagnostics also be possible by applying for LDT (Laboratory Developed Test) on a unit-by-unit basis, as they have operated with Aiforia’s products in the US, for example?
Are you sure? Dilution Tracker lists those, there are e.g. 1/2025 warrants whose conversion price was originally $0.252, after which a 1/60 reverse split was made which affected them and the current exercise price is 15.12.
I believe dilution will occur, but it’s hard to believe it will be at mere cent prices…! The latest financing round was an At-the-market offering where the discount was in the single-digit range.
I haven’t come across any FDA permit application either; apparently, the matter is on hold. The annual report contained the following mentions:
"We have previously invested in 3 multicenter clinical studies for postnatal, prenatal and hematologic malignancies analyses relative to SOC. The studies progressed and resulted in 4 multi-site peer-reviewed publications. The programs were designed to build the necessary evidence to establish reimbursement and to pave the way for inclusion in professional society guidelines to advance SOC. We are no longer investing in these programs. The AMA issued a category 1 CPT code for OGM in heme malignancies (code 81195) which was priced by the Clinical Laboratory Fee Schedule (“CLFS”) and effective Jan 1, 2025.
And
" We intend to establish additional collaborations with customers to help drive validating studies and expand partnership efforts with clinical diagnostic companies to commercialize LDTs in the U.S. as well as LDTs and approved tests outside the U.S."
And:
“Laboratory Developed Tests (LDTs) Federal agencies involved in the regulation of LDTs include CMS and the FDA. CMS regulates the quality of clinical laboratories and the clinical testing process pursuant to the Clinical Laboratory Improvement Amendments of 1988 (“CLIA”) and the FDA regulates the safety and effectiveness of the diagnostic test pursuant to authorities in the Federal, Food, Drug, and Cosmetic Act (“FDCA”). Although the FDA has statutory authority to regulate medical devices, the FDA has historically exercised its enforcement discretion and not enforced applicable provisions of the FDCA and FDA regulations with respect to LDTs, which are a subset of in vitro diagnostic tests that are intended for clinical use and designed, manufactured and used entirely within a single laboratory. The FDA does not consider devices to be LDTs if they are designed or manufactured completely, or partly, outside of the laboratory that offers and uses them. We sell our OGM systems on an RUO basis to CLIA certified cytogenetic laboratories, which may use the system to develop LDTs. 21Table of Contents On May 6, 2024, the FDA published a final rule on the regulation of LDTs which amends the FDA’s regulations to make explicit that LDTs are IVDs and regulated as devices under the FDCA. Under this final rule, over the course of four years FDA would phase out its general enforcement discretion approach to LDTs and begin enforcing requirements for premarket review and marketing authorization and compliance with certain elements of the QSR, registration and listing, medical device reporting, labeling, and corrections and removals reporting. Notably, implementation of the LDT final rule’s phaseout policy may be affected by the change in administrations. We may be required to conduct clinical trials prior to continuing to sell our existing LDTs.”
TLDR; I interpret that Bionano sells 1) services as Laboratory Developed Tests, where the sample is examined in Bionano’s own lab, and 2) Equipment for RUO (Research Use Only) – and other laboratories can convert this equipment into LDT tests. However, the last paragraph states that the FDA has tightened its practice in this point 2) and Bionano may have to conduct additional studies.
As a quick answer, warrants were discussed in the Q3 webcast, and perhaps that indeed applied price-wise before the reverse split (edit: I got confused in my previous hurried answer). There was actually something about some financial arrangements in the Q4 webcast or press release, but I don’t remember what anymore - I need to check the Q4 press release at least when I have time
(Edit: what I mentioned from the Q4 release was just repayment arrangements for a loan the company had previously taken, nothing related to dilution risk; you were certainly right that these cent prices no longer apply to Warrants, but they too would have been reverse-split…)
Pharmaceutical company Navamedic 
NAVA launched its over-the-counter erectile dysfunction topical treatment, Eroxon, in Denmark.
The launch marks the product’s fourth in the Nordics, following Norway, Sweden and Finland, according to a Monday release
Geelin valmistaja Futura ja Navamedic toimii ilmeisesti jakelijana/markkinoijana. Otin molemmista pari viikkoa sitten position. Navamedicin kurssi on performoinut hyvin, Futura on junnannut paikoillaan.
I took a small beginner position in Bionano. Now I have enough interest to delve deeper and follow it!
You mentioned that Bionano is the OGM market leader. Can you elaborate on its market position, share, patent status, i.e., potential future competition/moats? I quickly glanced at market research and saw that the current market size is around 140 MUSD, so the forecasted revenue is a significant share of that. Regarding the “moat,” I assume that once a user adopts Bionano’s system, especially if they validate LDT for clinical use themselves, these sample chips will likely be consumed over time, and the system won’t be easily switched. On the other hand, the customer base is relatively small (or rather, these hundred-plus routine users, a number that cannot be strongly increased to save cash) and not growing strongly in the near future, so will someone else with better resources overtake them? Operations have been significantly scaled back to save cash.
If, however, labs use (if clinical analysis with OGM becomes common, which the expert recommendation you linked gives hope for) Bionano’s LDT-validated system by sending samples for them to analyze, there is no similar moat, and switching to another equipment provider/service provider later would be easy.
I’m wondering if there’s another major player with a large market position and better financial resources to push through their own system, if, for example, in hematological cancers, this becomes routine in diagnostics within a year or two?
Additionally: do you know what “discontinued clinical services” means, which was mentioned in the Q4 report and earnings call? Also, referring to your interpretation above, that they would take samples into their own LDT-validated lab for analysis. Does this refer to other clinical analysis services, or specifically OGM analysis suitable for clinical use performed as a service in their lab?
FOMC day and earnings report soon, fortune favors the bold 
Apparently the market share is 100%. At least all OGM studies I’ve read regarding genetics or blood cancers have been done with Bionano’s equipment. https://www.perseusbiomics.com/ apparently uses a similar optical method, but their focus is on studying gut microbes…
I would think it’s easier for a big player like Revvity, Thermo Fisher, etc., to just buy Bionano out; a lot of money has certainly been poured into that. I don’t believe a competing system can be created with just pocket money…
From the annual report: “As of December 31, 2024 the Company had $15.5 million of principal outstanding under the Debentures (see Note 9 (Debt) to our consolidated financial statements) and an accumulated deficit of $693.2 million. In 2024, the Company used $68.9 million of cash in operations.”
I don’t quite get it; commercially available OGM equipment is, to my understanding, only Bionano’s. Samples are analyzed either in Bionano’s own lab or in another lab where Bionano’s equipment has been sold. Profit comes from chips and reagents.
If the market share is 100%, then there’s “no worry.” I was thinking, if there are a few direct competitors coming, as long as customers haven’t invested in the equipment and LDT (Laboratory Developed Test) approval themselves, but use Bionano’s lab, it would be easy to switch to another company’s product.
Retail investors seem to have quite gloomy sentiments about the company. No wonder, as the stock price has fallen to permilles of its ATH (All-Time High) due to dilution. Institutional investors seem to account for 2/3. Well, one must remember that the market value has dropped so insignificantly that not many millions are needed to acquire it. Do you know if there are “credible” parties among the financiers, e.g., through offerings? Were the previous offerings seemingly aimed at a wider audience?
It’s interesting, though, if the method starts to gain validation for first-line diagnostics and if the market share truly is 100%. I do wonder about that, as the size of the current market was mentioned in those market studies as several orders of magnitude larger than the company’s revenue. How was such a sum calculated then… or was the value chain calculated more broadly there…
My back-of-the-napkin calculation for blood cancers, USA:
Diseases where OGM is recommended as primary are roughly 50,000/year, and similarly, diseases where OGM is recommended as a supplementary study are also 50,000/year.
The test is recommended at the time of diagnosis, as well as in cases of relapse and transformation.
Let’s assume 80% penetration for primary indications and 40% for secondary indications. 2 tests per case = 120,000/year.
The Q4 earning call mentioned a figure of $1300 per test, which was perhaps the CMS reimbursement rate? I haven’t found how much Bionano actually earns per test, but I assume at least that much.
This already gets us somewhere. Then I would also include EU5, Canada, Japan, and South Korea. And then some realistic estimate of when this can be achieved…? Outside of hematology, the next biggest application area, as I understand it, is prenatal screening, but I haven’t given its scale any thought yet.
And indeed, this is not some Revenion iCare that anyone can learn to use in five minutes. Adoption happens much slower. On the other hand, I believe the threshold to switch to another later is very high, and currently, there is no competition.
I look at the company’s presentation TAMs with a very strong filter, they are aimed at investors 
That’s a good question then, how long it would take to reach that sample volume. Two to three years might be too optimistic a way of thinking. It’s probably not entirely unrealistic that the company’s market value could rise to, for example, a billion if that is achieved - it’s another matter how much dilution has occurred by then…
Delcath (DCTH Nasdaq)
https://investors.delcath.com/investor-relations
The company received FDA approval last year for its device/chemo (Hepzato) combination for the treatment of metastatic uveal melanoma that has spread to the liver. In practice, the liver is isolated from the bloodstream, filled with a toxic substance, and the chemo is filtered out of the blood before it is pumped back into the patient. This cancer is rare and most commonly spreads to the liver. Because this cancer is relatively rare, the TAM (Total Addressable Market) is relatively small, but a clinical trial has now been initiated for the treatment of breast cancer metastases to the liver using the same method, where the TAM is approximately 7 times larger. Furthermore, colorectal cancer is in the research pipeline. Results for these are expected in 2027 / 2028. Some interim data should be available before then.
The company just released its Q1 / 2025 results, which exceeded expectations (I can’t be bothered to translate):
- Total revenue of $19.8 million, compared with $3.1 million in the first quarter of 2024
- HEPZATO KIT™ revenue of $18.0 million, compared to $2.0 million in the first quarter of 2024
- CHEMOSAT® revenue of $1.8 million, compared to $1.1 million in the first quarter of 2024
- Gross margins of 86%, compared to 71% in the first quarter of 2024
- Net income of $1.1 million, compared to a net loss of $11.1 million in the same quarter of 2024
- Non-GAAP positive adjusted EBITDA in the first quarter of $7.6 million, compared to a loss of $7.3 million in the first quarter of 2024
- Cash and investments of $58.9 million as of March 31, 2025
- Cash provided by operations of $2.2 million in the quarter
So, debt-free, cash-rich, and already profitable. Currently, there are 19 hospitals in the US performing these procedures, with a target of 30 hospitals by the end of the year.
There is no comparable device/drug competitor for uveal melanoma that has spread to the liver, and the life expectancy and probability of disease recurrence for Kimmtrak (drug), the closest treatment for uveal melanoma, are worse.
The undersigned started investing at the $5.5 USD level after they received FDA approval, and my own (greedy) investment case is to wait until FDA approval for breast and/or colorectal cancer treatments breaks the bank 
or until a larger entity acquires it.
Regarding risks, the CEO states that there is enough money for the aforementioned clinical trials. R&D costs will increase in H2 / 2025, and there is a risk that the results will turn into a loss. However, the cash reserves should be sufficient in any case. Trump is another (and perhaps bigger) risk with his plans to lower pharmaceutical industry costs for consumers. But then pretty much the entire industry goes down at once 
So now @Antti_Siltanen, it’s May and you need to give your opinion on Covalon, i.e. COV.V, as you promised
On Salkunrakentaja’s website, profitable European small-cap companies were listed, and VISTIN PHARMA ASA caught my eye from there.
The company globally produces 10% of metformin, which is used for type 2 diabetes. It has been producing for 50 years and has aimed to keep up with development through production automation. It is therefore a manufacturer of the active ingredient for diabetes medication, meaning its business idea is different from that of drug developers or marketers.
According to the company’s presentation, the metformin market grows 4-6% per year, meaning organic growth seems to be in good shape. To my understanding, no basic medications for type 2 diabetes are coming for a long time, especially none as cost-effective.
Offhand, I can only think of one downside: that the company is located in Norway and pays dividends, meaning part of the return would have to be claimed with significant effort.
Link to Q1 2025 presentation
BNGO Q1/2025
- Total Revenue: $6.5M, -26% vs Q1/2024 (comparable figures include discontinued operations)
- Flowcells Sold: 6,994 units in Q1 2025, a 15% decrease year-over-year; however, a 1% increase when excluding new customers.
- GAAP Gross Margin: 46% in Q1 2025, up from 32% in Q1 2024. vs 42% Q4/2024
- GAAP Operating Expense: $11.4 million in Q1 2025, down from $33.9 million in Q1 2024, vs $15.4M Q4/2024
- Installed Base of OGM Systems: 379 systems, a 9% year-over-year increase.
- Cash and Cash Equivalents: $29.2 million as of March 31, 2025, with $11 million subject to restrictions.
- Cash Runway: Expected to extend into Q1 2026.
- Full Year 2025 Revenue Outlook: Expected to be in the range of $26 million to $30 million. (previously $29-32M)
Investor Call Highlights: “oncologists at MD Anderson Cancer Center are reluctant to manage their patients without the OGM results.” - Cancer hospital number 1 leads the way.
“of the number one questions that is asked when somebody is evaluating optical genome mapping is whether there is a CPT code for it.” - This has been active since Q1/2025.
-15-20 new systems per year expected. However, 80% of revenue still comes from the core user base, but critical mass towards profitability is being reached.
-The implementation of the system and software (VIA, powered by NVIDIA) into practice is done one research indication at a time, e.g., AML. It is not a plug-and-play system.
-With OGM technology, approximately 18% of MDS blood cancer patients achieve treatment-influencing results, results that cannot be obtained quickly and cost-effectively by other methods (WGS costs 5-10x OGM+NGS). This was already known, but the understanding is reinforced that this is not some academic tinkering by a few geeks, and research evidence for other cancer types is continuously accumulating.
So, revenue is flat considering discontinued operations, the cost-cutting program has tightened further, and GM% has been raised, cash for a year, technology already in daily use in at least one leading center. The stock reacted in after-hours trading with approximately +20% on a volume of just under two million dollars.
Regarding the numbers, at least concerning revenue forecasts, there was a “mild negative earnings warning,” and no positive surprise in revenue, while costs and thus gross margin are developing quite nicely. What do you see as particularly causing the big stock price increase in the aftermarket? The lack of a “negative surprise”? The continued positive development of costs/EBITDA? The “validation” of the benefit of clinical diagnostics based on the MD Anderson anecdote (+ of course, the previous working group’s positive recommendation on clinical benefit in blood cancers, but that was no longer new information)?
Do you believe that with the stock price increase, a new share issue will soon be sought? I’m wondering if the stock price might still dip a bit when financing is sought? That could be quite soon.
Did you find out how much the cash flow is negative/quarter now? Opex probably won’t decrease much from this point.
Operating cash flow -2.76M vs -28.1M Q1/24
So a lot has been trimmed, and such an abrupt slowdown cannot have failed to affect revenue growth
Thank you. That sounds really good, especially if (for assumed routine users, according to the sales forecast for new devices!) we get even a slight increase in the number of flowcells sold and maybe some start expanding into new indications. This could become cash flow positive soon. I bought a bit more stock after this information 
(Edit: apparently FOMO struck for nothing 
)
Bionano also gets a category I CPT code for analytics performed in fetal screening. The market will certainly reward with a decline, or most likely won’t even understand. On Stocktwits, the air is so thick you could cut it with a knife.
Here is SalkunRakentaja’s article about Moderna and the FDA decisions benefiting it.
Subheadings:
- Vaccine reliability improves
- FDA’s new rules shape Moderna’s strategy
- Moderna’s stock at rock bottom
Psychedelic Therapies for Depression and Other Psychiatric Indications, Gaining Momentum?
There was a strong buzz around psychedelic companies a few years ago, but since then, valuations have dropped close to the ground (which, of course, applies to biotechs more broadly as well). Good results have been obtained for several molecules up to Phase 2 level, but in addition to the general biotech downturn, there have been other headwinds for valuations. Examples include considerations regarding practical commercial scalability (because it would not be a tablet package sold in a pharmacy, but requires several hours of support and monitoring on the treatment day by a trained healthcare professional, and there could be a bottleneck in scaling up), and uncertainties regarding the FDA’s approval process (blinding in studies is difficult to implement, because the psychedelic experience is clearly noticeable to the subject, which can guide the subject’s expectations of the drug’s efficacy; this was one of the most significant reasons why Lykos Therapeutics’ post-Phase 3 marketing authorization application was rejected less than a year ago, and a new Phase 3 study was recommended. Another essential point was that it was MDMA-assisted psychotherapy for PTSD treatment, and the drug’s effect is difficult to distinguish from the therapy’s effect, and the evaluation/supervision of psychotherapy generally does not fall under the FDA’s purview; furthermore, deficiencies were observed in the safety data). All in all, these stocks are currently languishing at ATL (All-Time Low) in April 2025. (And a large part of the companies have faded away, with a few selected ones remaining.)
I have personally followed Compass Pathways in particular, as its studies are the most advanced. The company is researching the efficacy of psilocybin for treatment-resistant depression (TRD; depression that has not responded to 2-4 different antidepressant treatments). In the USA, apparently about 30% of clinical depression turns out to be treatment-resistant, so this is a potentially large market. In the competitive landscape of drug treatments, esketamine nasal spray (Spravato) has been approved for the TRD indication in recent years; there are no other direct competitors in drug treatments (except off-label i.v. ketamine; Spravato has apparently taken a large share of ketamine therapy, and sales of over a billion dollars are already being discussed). Spravato is also administered only on an outpatient basis, meaning it is not home care, and the dosing regimen is frequent, initially twice a week, at some point changing to once a week, and later, for example, every two weeks. A treatment that ties up patient time and healthcare resources.
Compass is completing a Phase 3 study (comp005); dosing for the last patient was completed at the end of March. Preliminary 6-week response results are expected at the end of June. In this phase, the efficacy of psilocybin is compared to placebo, and topline results will report the efficacy difference on the MADRS scale, p-value, confidence interval, and the comment of an external oversight body regarding safety. The molecule should not have toxicity; particular attention is paid to a possible imbalance in suicidality between groups regarding safety.
Compass also has another Phase 3 study (comp006) underway, which does not use a pure placebo, but compares the efficacy of the treatment dose (25 mg) to 10 mg and 1 mg doses, and this is intended to overcome the “functional unblinding” problem, meaning that subjects will have a less clear idea of whether they received a dose considered effective or not, and a dose-dependent efficacy difference in favor of the treatment dose would demonstrate the medication’s efficacy and minimize the patient’s expectation effect on perceived symptom relief. Compass’s Phase 2b was conducted in the same way (nearly three hundred patients, efficacy difference at 6 weeks of 6.6 points on the MADRS scale with a p-value less than 0.01, article published in NEJM). This is the company’s preferred study design, but the FDA also required a comparison to a pure placebo to ensure more solid safety data. Compared to 2b, comp006 involves 2 doses (which, based on some studies, appears to increase efficacy) and the primary endpoint is response at 12 weeks (a longer response/remission is, of course, a positive thing, as it would allow for dosing, e.g., a couple of times a year/upon relapse).
The company has emphasized that psychedelic therapy is administered with psychological support, not psychotherapy. This involves informing about the nature of the treatment, providing psychological support during the treatment if needed (but in practice, most of the time the patient lies with eyeshades on and focuses on their own experience), and some kind of integration sessions after the treatment. According to the company, there should not be a similar problem of confounding the therapy’s effect as with Lykos…
I apologize for perhaps too long a background. However, the industry is apparently eagerly awaiting the first Phase 3 results in a month. Furthermore, possible tailwinds can be sensed from the new US administration, or at least the atmosphere should be as positive as possible regarding this traditionally controversial treatment method. Trump’s friend Elon has long publicly spoken about the benefits of psychedelics. Robert F. Kennedy, selected to lead HHS (I’m not commenting on the person here 
), has expressed positive opinions, especially regarding psilocybin treatments (apparently, his son once received significant help for his mental health problem from such a treatment). Martin Makary, selected to lead the FDA, spoke positively about psilocybin/psychedelic therapy in an interview last week and defined one of the FDA’s priorities as making these treatments available to patients as quickly as possible, if data supports it, to overcome the national mental health “emergency.” Furthermore, Trump has appointed Casey Means as Surgeon General, a national medical role model, who has also been a public advocate for psychedelic therapies, and has also stated that she herself underwent psilocybin therapy, reported benefiting greatly from it, and encouraged people to explore psilocybin therapy if they “feel a calling to the matter.”
In addition, regarding psychedelic therapies, the administration has brought up a topic generally sympathized with by the public, namely the potential treatment of treatment-resistant mental health problems in war and other veterans (PTSD and related/confounding TRD), and Compass is now working on a Phase 3 plan for PTSD; good results were obtained in a relatively small previous Phase 2 study, but to ensure sufficient cash, TRD phases were prioritized in the recent past; a large cash replenishment was sought through a directed offering in the spring, and now it seems they have decided to strike while the iron appears to be hot again. Perhaps spinning the issue around veterans could be a good way to approach the public on a controversial matter, if those controlling the media space have goals to promote the cause?
Thus, if the upcoming research results are encouraging, it might be possible that the investor sentiment around the issue and the company could become favorable, and perhaps the media could even generate widespread enthusiasm, if the agenda of the administration’s healthcare leaders has been positive?
I have also considered that perhaps in this soon-to-be-completed study comparing to placebo, it is RELATIVELY easy to get a good-looking result, because in Phase 2b, active and minimally active doses were already compared, and yet with statistical certainty in a fairly large patient population, a better efficacy than Spravato was shown between the largest and smallest doses, and since only the MADRS difference is presented in the topline, not the absolute magnitude of the placebo group’s response → assuming the patient material remains otherwise similar, one would not expect a clearly worse efficacy difference, would one? (That is, the placebo response would be expected to be smaller if the patient notices they have not received an active drug dose and thus “had bad luck” and their desired treatment was not received for now. Therefore, it might be easier to show an efficacy difference in the MADRS reduction in this study).
Above all, I would welcome challenges/critical opinions on a moderately risky case, but one that perhaps already has short-term positive potential!
You’ve already analyzed it well, my own thoughts:
It’s a shame that during the moral panic of the 60s, when it was noticed that young people started enjoying marijuana haze and it was feared that the entire USA would regress to the level of an opium den and that work and striving ever higher would no longer be of interest, let alone warfare, psychedelics like LSD had to be banned even from research use. Psilocybin affects the same serotonin system but is milder and thus easier to use. In recent years, there has been a renewed interest in considering this therapeutic “opening” effect. Fortunately, these lack addictive properties. Someone might want the same experience again, but it cannot be compared to hard drugs.
In Finland, there still seems to be a requirement for simultaneous psychotherapy and it’s only for research use. Furthermore, the substance cannot be taken without professional help, as a bad trip might occur, leading to severe anxiety.
Magic mushroom growing kits are sold by, for example, Wholecelium. A reminder here that in Finland, according to the law, it can be criminal, condemnable, reprehensible, unforgivable, etc. Some also find liberty caps (suippumadonlakit) in Finnish nature, and the same reprehension applies, etc. Damn hippies, etc.
Mainly as an investment, especially regarding psilocybin, one considers that it’s not a big problem to “manufacture” it oneself, the substance is not patented, so where is the edge to sell it? Many would, of course, prefer to take it as a pharmacy product rather than “roughly” from a mushroom without knowing the concentration. Perhaps not many uses are needed in a lifetime for a therapeutic effect, so where is the continuous business?
MDMA, or “ecstasy”, which should therefore contain MDMA, cannot be manufactured very easily, but it is not protected by a patent either. Does MDMA require more simultaneous psychotherapy? Indications for use are more limited than for psilocybin, which has depression etc. as an indication, and there would be plenty of those.
For both substances, manufacturing method and other patents can be, and probably have been, applied for, but there is still a risk that protections are lacking. Unlike new drug molecules. One view is that there could be great benefits for mental health, and one would inherently want to support research and promote its use, but would there be significant continuous financial returns?
The depression market itself is large; as a rule of thumb (per Prof. Isometsä), 1/3 genuinely receives help from antidepressants pharmacologically, 1/3 receives help from the aforementioned medication as a placebo effect, and 1/3 receives no help. Electroconvulsive therapy, magnetic stimulation, ketamine-derived treatments, and now these psychedelics come to the rescue. Not forgetting psychotherapy, as supportive therapy in almost every case, emphasized as effective “monotherapy” for mild depression.
I haven’t delved into Compass, but remissions were observed there per MADRS, again about 1/3, with the highest dose vs. mini-dose. I don’t doubt at all that it wouldn’t work for depression. The patient and caregiver certainly notice the difference between placebo and psilocybin, a truly difficult setup.
Regulatory approval would indeed be essential. But then almost free competition would be available. How long would the first to market benefit? What would be the price of the medication for one or two doses, when the psychological supportive therapy, which might last weeks, also needs to be paid for? And administering the medication in the presence of professionals, that effect will take up an entire workday.