One Year After FDA’s MDMA Rejection: Insiders and Observers Reflect

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Last August, Lykos Therapeutics announced that the U.S. Food and Drug Administration (FDA) had issued a Complete Response Letter (CRL) to its new drug application (NDA) that sought to have MDMA-assisted therapy approved for PTSD. In real terms, the agency had rejected Lykos’ first shot at getting the drug approved.

After a period of intense reporting last year, we shifted focus to what the future looked like for Lykos as well as its peers.

Our key coverage of ICER and FDA’s review of Lykos’ NDA last year included:

As we covered insiders’ reactions, at some point it didn’t seem helpful to continue rehashing the same old debates, especially as a few entrenched schools of thought emerged¹, which included:

‘Psymposia torpedoed it’
‘Big pharma sunk it’
‘Lykos fumbled it’

While we have attempted to push past these tired debates and adopt a more forward-looking stance in our reporting, they still loom large in the field.

In March, journalists Andrew Jacobs and Rachel Nuwer penned a New York Times piece that said Psymposia, which it described as “a leftist activist group”, ‘torpedoed’ MDMA’s chances of approval, reigniting a heated discussion surrounding the loosely organised nonprofit.

At Psychedelic Science 2025 in Denver earlier this summer, the blame game again resurfaced. Notably, panellists at a pre-conference business workshop titled Founder Narratives and Finding Capital in the Psychedelic Industry discussed the various factors that led to the NDA’s downfall.

Then, just two weeks ago, journalist John Semley wrote a piece for Wired that recounted last year’s saga once more, in an article that was at least partially a profile of Psymposia.

So, the debates—and animosity, to some extent—are alive and well. But as we pass the one-year anniversary of FDA’s CRL, we decided to do the rounds and speak to various people close to the matter.

We asked those individuals whether they believe, with the benefit of a year’s hindsight, the agency’s decision was surprising and/or justified, and what Lykos could have done differently. True to a more forward-looking orientation, we also asked them about the path ahead for Lykos, and the future of the field more generally.

In this lengthy, interview-led deep dive, you will hear from MAPS founder Rick Doblin, a former Lykos executive familiar with the contents of the CRL and the company’s strategy, other company insiders, members of that apparently fateful FDA Advisory Committee (AdComm), critics of the program, investigators and academics, and investors.

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Was FDA’s Rejection a Surprise? Was It Justified?

While many in the field believed FDA approval of MDMA was a shoo-in back in early 2024, that optimism began to wane following a negative ICER report, a very negative FDA AdComm, and plenty of attendant media attention. In some sense, then, the writing was on the wall by the time that news of FDA’s CRL came in August.

But even when taking a longer view, some people we spoke with weren’t surprised by the agency’s decision.

Jessica Eisner, who spent four years in the FDA’s Center for Drug Evaluation and Research (CDER) and is now a Venture Partner and Scientific Advisor to Lionheart Ventures, was not quite as hopeful for approval as many psychedelic insiders, for example.

“Three years ago, when I first started investing in companies developing psychedelic drugs, Lykos was barely on my radar”, she told us, “because I couldn’t decipher the MAPS-Lykos relationship, or their operational model for getting MDMA through clinical studies to approval for treatment of PTSD.”

Another psychedelics outsider-cum-investor, Palo Santo Partner Edny Inui, said that when she joined the venture fund in late 2023, she “carried a far more cautious outlook than the optimism I witnessed at Psychedelic Science 2023.”

That perspective, she said, was borne out of a decade of experience in biotech, especially a stint at Biomedtracker early on in her career. Indeed, drawing on data from that firm published in Nature Biotechnology, Inui told us that “only about 36% of neurology drugs are approved on their first FDA review — the lowest of any major therapeutic area, and neuropsychiatry isn’t far behind.”

So, when she first assessed Lykos’ likelihood of approval on its first attempt, Inui marked it below the ~50% industry average.

Another Palo Santo partner, Daniel Goldberg, also noted that—for people with “deep experience in biotech and pharma”—the CRL was perhaps less of a surprise. “They didn’t probability-weight it quite as favourably as the psychedelic community”, he told us.

“Don’t get me wrong, it felt like a gut punch at first, but looking back, the caution we heard from those with pharma experience now seems more justified than many in the psychedelic space were willing to admit”, he added.

Those in the psychedelics bubble, then, might have been overly optimistic.

Surprised or not, some observers—particularly those outside of the psychedelics space—certainly believe the agency’s decision was justified.

One of those is Joar Øveraas Halvorsen, an associate professor of clinical adult psychology at the Norwegian University of Science and Technology and clinical psychologist at St. Olav’s University Hospital, who has consistently raised issues around Lykos’ program, including to the FDA AdComm via written comments (PDF).

“Based on the publicly available data, I do believe that the FDAs decision was justified”, he told Psychedelic Alpha.

He thinks that the “level and amount of public hype for an unapproved treatment” seen around MDMA for PTSD was virtually unprecedented. That, combined with difficulties in blinding participants, “contributed to the uncertainty regarding the estimates of the treatment efficacy”, he said.

He believes that, given “important methodological limitations, including functional unblinding, strong expectancy effects, and recruitment from a community with strong prior beliefs in psychedelics”, the agency was justified in its rejection.

There will be no surprises at the line that Psymposia is taking. Speaking to Psychedelic Alpha, the group said that it believes the FDA’s decision was justified.

“While much attention has focused on blinding issues, the more significant concern is functional unblinding occurring within a context where participants and staff held strong beliefs in what amounts to pseudoscientific therapy”, it said.

On the other hand, one former Lykos executive told Psychedelic Alpha that they believe the agency should have taken into account the unmet need and “tremendous patient burden” among PTSD sufferers, opting to allow for a limited approval as opposed to a rejection.

That limited approval could have covered only the acute use of MDMA, with a three-dose lifetime limit, pending a long-term study. The former insider described that potential compromise as “a short-term approval with a rigorous REMS to control distribution and use, as well as a post-marketing study requirement.”

Psychedelic Alpha understands that this is what Lykos sought from FDA last September, but the agency at that time insisted on seeing long-term data ahead of an approval.

Meanwhile, investor Brom Rector, who has been following the psychedelics field for many years and is the founder of XEIA Venture Partners, takes a more meta view, pointing to the incentives that FDA reviewers are exposed to.

“They risk looking bad or career damage if they approve a drug that ends up hurting people”, he told us, “but there are seemingly zero consequences if they reject a drug that would have helped people.” That leads reviewers to be overly cautious, he believes.

Amanda Wiggans, a strategy and insights manager at consulting firm ZS, wouldn’t go so far as to say the FDA’s decision was justified, though she did say it was “certainly understandable”.

Why Did FDA Say ‘No’?

Indeed, it is difficult to assess whether surprise is warranted or whether the agency was justified without looking to understand its main reasons for rejecting the application. While we have previously reported on these factors, there are varying opinions around the salience of any given one.

Responses here can be broadly split into two categories²: issues or decisions internal to Lykos (such as those related to trial design and conduct, but also corporate decisions around communications) and those external to it (such as the ICER review process, Psymposia’s intervention, and the institutional dynamics of FDA).

On the internal front, many insiders and observers pointed to Lykos’ safety data package, noting a lack of long-term data and spotty data on adverse events seen during patients’ MDMA sessions.

One former executive, who is deeply familiar with the CRL and spoke to Psychedelic Alpha under the condition that their name not be shared, said that concerns around safety data were top of mind for the agency.

The safety data was not presented in a rigorous way, the former insider told us, adding that Lykos failed to adequately present a detailed account of ‘adverse events’ that patients experienced during dosing sessions.

The former exec acknowledged that it’s a tricky task, coding the many events that might occur during an eight-hour dosing session, but that this is what the agency expected to see. “The company basically made a mistake in not doing that”, they said. “[FDA] did emphasise it, so the company should have done it.”

A key question that has swirled since this matter came to light is why Lykos did not collect this data in a rigorous manner. Did it misunderstand what was expected of it, for example, or was it low on resources?

“It was, I think, hubris on the part of some people at the company”, the former exec told us, adding that those individuals “sort of said, well, these aren’t adverse, they’re part of the therapeutic process.”

Aside from this, a lack of long-term data hamstrung the company’s ability to achieve a meaningful approval, the former insider believes. ‘Medical professionals need to know what happens if the patient isn’t completely better after three doses’, they noted, adding that the lack of such data raises questions like: ‘Can I give a fourth?’ Or, ‘What happens six months down the road if they relapse? Am I allowed to give a fourth or fifth dose?’

While this lack of data could have muddied the clinical and commercial case for MDMA in PTSD, it also gave the FDA cold feet, the former company exec suggested.

Lobbyist Charlie Panfil, a VP at DB3 who works on psychedelics matters, among other things, agrees that the lack of key safety data was likely a significant factor in the agency’s rejection.

“People in this space knew FDA approval would be challenging, yet we saw an initial package that was missing basic heart and liver data and follow-up information expected in FDA submissions”, he told us.

“I understand that this research was conducted over a long period and occurred before Lykos became a pharma company,” he continued, “but it highlights that nonprofit advocacy groups should not turn into pharma companies seeking FDA approval.”

Kim Witczak, a patient safety advocate who served as the Consumer Representative on last year’s MDMA AdComm, told Psychedelic Alpha that she was also concerned by “missing basic safety assessments like QT interval and liver monitoring”.

But Witczak has a broader list of concerns, which includes commonly-discussed thorns in the NDA’s side like functional unblinding (more on that below), selection bias, lack of a comparison to “other evidence-based therapy models”, and “inadequate safety guardrails, particularly in light of past therapist misconduct in trials.”

On that latter point, Witczak is insistent that “allegations of trial misconduct from former participants, investigators, and employees […] must be fully investigated for any approval.” She would have preferred it if the agency’s investigations had concluded prior to an AdComm being called, “so it wasn’t still an open question”, she told us.

Wiggans also seems to think that the ‘open question’ that Witczak points to around misconduct had a substantial impact. She doesn’t believe that cardiovascular risks or functional unblinding were the decisive factors in the CRL, and told us that, based on speaking with people involved in the company during the review period, “the FDA had generally signalled support to the Lykos team leading up to the June Advisory Committee meeting.”

The consultant thinks that “the real turning point came when the therapist misconduct surfaced.” “At that point”, she told us, “approving the therapy would have exposed the FDA to intense public scrutiny”.

“Considering the already controversial approval of Spravato despite questions around its efficacy and safety,” she continued, “it’s not surprising that the FDA would approach the first psychedelic-assisted therapy with heightened caution—even if the misconduct was limited to a single (reported) case.”

Without the integrity of the Phase 2 program being queried, Wiggans believes there would have been a strong likelihood of approval.

MAPS founder Rick Doblin also believes that the AdComm was a watershed moment for Lykos’ hopes of MDMA approval. He therefore thinks that the most decisive factors that led to the CRL are those that led the AdComm to recommend against the therapy, along with some of the ways in which Lykos “acted in the two months between the AdComm’s negative recommendation and the FDA rejection.”

Indeed, Doblin seemed to lay most of the blame at the feet of Lykos’ own internal decisions, depicting the downfall of the NDA as a kind of ‘skill issue’, in Gen Z speak.

Still top of Doblin’s gripes is the company’s decision to hold a quiet period during the submission and review process, a “traditional pharma strategy” that he believes left a vacuum in which critical voices could thrive. “The critics were a key factor”, he told us, “but they succeeded due to the failures of Lykos management.”

Indeed, Doblin thinks that much of the fuss about functional unblinding could have been countered by management, starting with the ICER report, which the company did not engage with.

“Then the Washington Post and other media discussed the ICER report’s concerns about functional unblinding and Lykos still failed to explain or defend the clinical trial design and why FDA itself selected inactive placebo over low-dose MDMA”, Doblin continued. More on that below.

What’s more, the MAPS founder thinks that the company “failed to rebut accusations of bias and lack of safety”, adding: “Lykos management wanted to be a traditional drug company selling MDMA and didn’t want anything to do with therapy, therefore alienating the therapists and not inviting them to explain and defend the therapeutic approach to the AdComm.”

He also thinks that its “refusal to permit [an] academic study of touch left Lykos without a useful counterpoint to accusations of therapist boundary violations and sexual abuse that occurred in one patient about ten years before the AdComm meeting”.

Here, Doblin is referring to a group of academics who apparently approached the company in 2022 with an offer to study the role of touch, “entirely at their own expense”. Lykos declined both the offer and a request to access study session videos, Doblin says, “despite repeated appeals from the MDMA therapist alliance and me saying that better understanding the use of touch was clearly in the best interests of patients.”

The MAPS founder also takes aim at Lykos’ decision to ‘shut down’ its ex-U.S. research and regulator engagement, such as its European program and its engagement with Health Canada and the Israeli Ministry of Health.

“This left FDA as the only regulatory agency reviewing Phase 3 data when regulators prefer to be acting in harmony with other regulators.” “Lykos also lost out on regulatory competition to be the first to approve breakthrough and innovative therapies”, he added.

But others lay at least some of the blame at Doblin’s feet.

Some, for example, said that he was too idealistic in his ambition to ‘educate the FDA’, as opposed to playing strictly by its rules.

One former insider told us that the MAPS founder’s insistence on foregrounding the psychotherapy element ran contrary to the agency’s wishes, and expressed frustration with his lack of compromise in that realm.

Another suggested that Doblin’s inviting of ICER to conduct its report, ahead of FDA approval, was ‘one of a couple of self-inflicted wounds’.

Still, most people we spoke with accepted Rick’s view that the AdComm was a key turning point, after which the likelihood of FDA approval nose-dived.

But Panfil, speaking at a pre-conference workshop at Psychedelic Science in June, was keen to emphasise that the public comment section, specifically, of that day’s proceedings was not the main issue for Lykos.

The lobbyist rejected the ‘Psymposia torpedoed it’ angle, for example. “I don’t think a single member of Congress, with the exception of two or three, knows who Psymposia was”, he told the audience in Denver, while also downplaying the group’s impact on the FDA review.

He doesn’t believe that anything that came up during the public comment period was crucial. Based on what the FDA had shared in the first two hours alone, he believes, it was clear that it was not likely to approve.

Speaking this week to Psychedelic Alpha, Panfil had a similar tone. “For me, the AdComm’s decision was predictable even before we reached the public comment section of the meeting”, he reiterated.

But even former Lykos employees who didn’t appear overly eager to lay the blame squarely on Psymposia, and instead were ready to point out the company’s own missteps, were insistent that the group’s advocacy was destructive in a significant way.

Elsewhere, Jennifer Mitchell, a UCSF neuroscientist and Lykos study principal investigator, told us that she feels there were many issues with how the AdComm was conducted.

“It appears that the AdComm meeting influenced the FDA’s decision to reject MDMA”, she told us, before bemoaning the panel’s apparent “lack of understanding regarding how the data were collected and what the data meant”.

Mitchell said that the panel also made comments “suggesting they were swayed by public testimony from speakers who had no tie to the phase 3 program or to the new drug application”. “The AdComm members suggested that something nefarious might be in play”, she added.

“I blame this last part on the FDA”, Mitchell continued, arguing that the agency would not allow members of the public to “pop in and talk about an undisclosed friend/relative who took a different cancer drug in a different study and felt they experienced bad side effects.” It’s too tangential.”

“Yet”, she went on, “that happened numerous times during the MDMA AdComm, and it kindled bias.” “Frankly, I’ve never seen anything like it.”

The much-discussed functional unblinding issue, meanwhile, is an instance of internal decisions potentially interfacing with external factors, such as the agency’s developing view of the phenomenon’s impact on results over time and a changing of the guard.

While observers like Øveraas Halvorsen believe that functional unblinding was a key driver of issues in the dataset, others, like Doblin, believe that the company could have done a better job defending itself against those charges and pointed to the role of functional unblinding in other products or candidates. It could have also emphasised, he told us, the agency’s role in deciding on the control group used in the Phase 3 studies. Again, more on that below.

Palo Santo’s Goldberg wondered: “Are there double standards related to psychiatric drug reviews compared to other therapeutic areas?” “Maybe, but it’s our responsibility to meet the FDA’s current standard”, he told us.

“We can’t expect them to lower the bar for us, even if we believe the need is urgent or the mechanism is novel”, he continued.

What Should Lykos Have Done Differently?

In terms of how Lykos might do things differently if it were offered a re-run, unsurprisingly, individuals’ prescriptions were largely based on the factors that they deemed most decisive in the agency’s rejection.

Nobody expressed more regret in this realm, however, than Doblin, who discussed at length with Psychedelic Alpha what he would do differently.

Unsurprisingly, his top prescription would be to scrap the quiet period strategy, which he described as a “disastrous decision”. He also regrets the MAPS Board’s “failure to push back” on the company, “instead follow[ing] Lykos’ request to block MAPS and me from responding [to critics].”

Speaking at that pre-conference workshop two months ago, former Lykos CEO and present Board member Amy Emerson appeared to acknowledge that the quiet period strategy was less than ideal.

‘Most companies,’ she said, ‘if something starts to come up, they do everything they can to squash it.’

“But MAPS did not”, Lewis Goldberg, Managing Partner at PR company KCSA, which has clients in the field, interjected. ‘That’s not the MAPS way’, Emerson responded.

‘We made a mistake of not being more on top of it’, the former CEO said, referring to how the company handled the way in which allegations and an instance of misconduct were discussed in the public realm.

The company became quieter and quieter as the FDA submission approached and the review went on, she said, adding: ‘I think there were mistakes that were made’.

Goldberg said that the company should have ‘acted aggressively’ and ‘tamped down those [negative] stories”. (But, then again, quiet periods aren’t exactly ideal for a PR company!)

On the more specific side, Doblin said that, if he could go back in time, he “would not have tried to act with such scientific integrity.”

“Rather than using an inactive placebo with therapy as a control, I would have used low-dose MDMA of 40 mg, despite 40 mg making people uncomfortable and reducing the therapeutic benefits compared to therapy with inactive placebo”, he told us, alluding to discussions the company had with the agency ahead of its Phase 3 program. (We covered this in detail last August.)

Doblin also said that he did not anticipate a change in staffing at the agency, which saw some of the people the company negotiated with in the Division of Psychiatry leave. They were replaced with, according to Doblin, “new, more traditional people who simplistically prioritised the double-blind format, even when it would make it easier to find a statistical difference”.

He also believes Lykos failed to “educate” members of the AdComm on why the agency chose an inactive placebo, claiming the panel “seized on ‘functional unblinding’ as if it was both unexpected and easily avoidable.”

Lastly, Doblin told us he wishes he had established “quantifiable metrics for what we meant by public benefit” when he and colleagues created MAPS Public Benefit Corporation back in 2014.

Those metrics should have reflected “what’s best for patients” in the first instance, and should have been attached to compensation, he said.

“I didn’t anticipate that Lykos would become led by more traditional pharma people who saw public benefit as an unnecessary complication”, he added.

The former Lykos exec we spoke to, meanwhile, focused their prescriptions on the trial design and conduct side of things, versus Doblin’s corporate critiques.

The company should have been more diligent in collecting and reporting all events that could be considered adverse, they emphasised. This individual also believes an acute use approval, limited to three lifetime doses of the drug, pending long-term studies, should have been the strategy, as opposed to gunning for a broader approval without sufficient long-term data.

In a view that is clearly at odds with Doblin’s, and reflective of a deep rift between the MAPS founder and the company’s (at least former) management, the ex-Lykos insider told us that they also believe the company should have more clearly separated out psychotherapy and focused only on the ‘medication’.

This individual believes the role of therapy is likely crucial but that, from an FDA perspective, the agency “only has expertise in the medication part.” It does not possess the remit nor expertise, they told us, to tease the two apart.

Even more specifically, the individual suggested that the company should (have) pursue(d) a two-part labelling strategy, with the first piece stating that MDMA is indicated for PTSD, and a second statement adding that it must be used in conjunction with psychological support or psychotherapy. This would build on the precedents, they said, of bupropion for smoking cessation and Suboxone for substance use disorder.

Aside from being a more canny regulatory strategy, the individual believes that this label would provide greater flexibility, which could be in the interests of patients and their providers.

Lykos’ Path Forward

In terms of what the company should do now, opinions are again split.

In the immediate aftermath of the CRL, it seemed clear that Lykos would need to conduct a fresh Phase 3 study, designed in collaboration with the agency.

While one former executive told Psychedelic Alpha that they feel this is still the best way forward (“it would be best for the product”), others think that a new U.S. administration that appears amenable to psychedelic therapies, especially for veterans, and new management at Lykos can deliver a faster path to approval.

Doblin is one of those believers, and he’s betting that MDMA will be approved in the next 12 months. “Both HHS Secretary RFK Jr and FDA Commissioner Dr. Marty Makary have indicated that approving psychedelic therapies is a priority”, he told us, adding: “I think there will at least be some sort of partial approval in the next 12 months.”

Mitchell is also optimistic for an expedited path to approval.

“If both the FDA and the sponsor now conduct independent investigations into the phase 3 program and conclude that there was no collusion or inappropriate behavior or data mismanagement”, she said, “then my hope is that the FDA would approve on appeal and that additional side effects and durability data could be collecting through a tight REMS plan in phase 4.”

Palo Santo’s Goldberg, meanwhile, told us that the company’s new leadership and cash injection give “good reason to believe a successful resubmission is high probability within the next 1-2 years.”

But others are worried about how such an expedited path to approval might look, particularly if it involves political actors.

If the process appears to be politicised, “that’s not going to help with the average prescribing clinician”, one former insider told us, suggesting that such an image would make clinicians and doctors less likely to take a chance on MDMA.

Others emphasised that they do not believe the company has resolved the issues discussed throughout the review process.

“I have not seen convincing evidence that the core methodological concerns—especially those related to blinding, expectancy bias, and trial conduct—have been adequately addressed since the decision”, Øveraas Halvorsen told us.

MDMA AdComm member Witczak agreed. “While there’s been public discussion, I haven’t seen new data or regulatory action that fully addresses the core concerns”, she told us, adding: “It’s still unclear whether the FDA has thoroughly investigated the misconduct allegations, though I understand they’ve asked the company to run another Phase 3 trial, which may address some of them.”

Still, she thinks the company could get it done in the next 12 months. “It’s possible,” she said, “especially given the current political and cultural momentum behind psychedelics. But she again expressed concerns: “approving without first resolving these issues would be premature.”

Another MDMA AdComm member, who preferred to remain anonymous, was also unsure whether certain issues had been resolved.

“I have not seen any evidence that the FDA has investigated the misconduct allegations or other concerning issues raised by participants in the trials”, they said, but added that this “does not mean the FDA has not investigated these concerns as findings would generally not be made public or made available to the Adcomm outside a formal meeting.”

Elsewhere, several people we spoke to emphasised how common CRLs are, especially for first-in-class medicines.

“Getting a CRL on a first try is not uncommon in drug development”, Palo Santo’s Goldberg told us, noting that “it’s often a sign that the agency sees potential, but needs further clarity or data before moving forward.”

His colleague, Inui, concurred. “History shows that companies who use the time between submissions to address the agency’s concerns meaningfully improve their odds”, she said, adding, “Lykos has now had that opportunity to reflect, retool, and respond. In my view, that sets them up far better for a second resubmission.”

Even Eisner, who couldn’t make heads or tails of Lykos a few years ago, is now feeling more confident in the company’s chances of approval.

“They have torn down and rebuilt the company with experienced industry experts,” she said, “and appear prepared to start anew.” “Now, I am optimistic and have conviction that Lykos’ tenacity, focus, and commitment will result in FDA approval of MDMA to treat PTSD.”

It’s not clear, however, to what extent the company’s new leadership is prepared to strip its program down to the studs.

How the Decision Rippled Across the Field

The MDMA drug developer’s troubles with the agency had a spillover effect for the field, with other psychedelic developers keen to cast its issues as “Lykos-specific”.

Rector thinks that the “definite fallout” from the saga was “that most companies developing psychedelic drugs are going out of their way to point out that their treatment protocol does not include talk therapy”, noting that this appeared to be a key complicating factor for the agency’s review.

Doblin, unsurprisingly, sees this—“that psychedelic-assisted therapy itself is incompatible with FDA approval”—as precisely the wrong lesson to be learned.

“The entire field is moving away from therapy and trying to become like J&J’s Spravato”, he told us. “Pharmacotherapy in combination with psychotherapy is what’s best for patients”, he fervently believes.

Panfil, the lobbyist, told us that the FDA decision cooled off some policymakers’ interest in the field, or willingness to go out on a limb and back it.

“Many policymakers felt essentially duped”, he told us. “Sadly, advocacy groups that heavily lobbied Congress between the AdCom meeting and the FDA’s decision portrayed a much more optimistic picture of reality that fell apart last August”, he added, recounting “angry phone calls” he received “from Hill staff and others about what they had been told in meetings”.

Panfil also said that he has spoken to Members of Congress “who have pulled back on this issue after getting burned the first time they publicly supported PAT.”

He thinks that the agency must finalise its draft guidance for psychedelic trials. “Releasing a draft and taking over two years to finalise guidance that could prevent issues like those in the Lykos decision is poor governance”, he said.

Taking a more meta view, Palo Santo’s Goldberg thinks that the entire process “has been a necessary recalibration.” “The field is moving beyond hype toward greater rigour”, he believes, “and that’s what’s ultimately going to win the day.”

The Outlook Today: Hope After Hard Lessons

Indeed, despite a very challenging year for psychedelics, and Lykos in particular, the tide certainly seems to have turned. Almost all the people we spoke to expressed optimism about the future of psychedelic therapies.

That former Lykos exec who expressed some concerns around the direction of the company remains optimistic about psychedelic therapies in general, including MDMA. Psychoplastogens—whether classical ones or emerging new molecular entities—they believe, ‘will become standard of care for mood disorders like PTSD, and perhaps eating disorders and substance use disorders.’

Despite being on the opposite side of many debates with this individual, Doblin is also bullish. He’s more positive about the potential for a regulatory approval of psychedelic therapies, he told us.

Rector told us that, based on his interactions with other investors, a period of higher scrutiny of psychedelics-related programs following Lykos’ rejection appears to have given way to a more optimistic tenor today. He thinks that, in five years or so, there will be “at least a few FDA-approved psychedelic drugs whose sales—without ‘assisted therapy’—trajectory looks like Spravato.”

His optimistic outlook is buoyed, he says, by Spravato sales figures, promising readouts from the likes of GH Research and Compass Pathways, and “the seemingly positive tailwinds from the new US administration”.

Other investors are equally bullish. Palo Santo’s Adrienne Jo told Psychedelic Alpha that she sees a future, in the next five years or so, where the ‘gold standard’ includes compounds like psilocybin and MDMA, but also so-called next-generation molecules that are shorter-acting and have greater specificity.

Jo, a senior associate at the firm, said that she is more optimistic about the trajectory of psychedelic medicine than a year ago, pointing to growing interest from top-tier investors and established biotech and pharma companies.

Her colleague, Inui, agrees. “When I look ahead at the next five years in psychedelic and neuroplastogen research, the horizon feels wide open”, she told us. Inui also pointed to next-gen psychedelics, institutional interest. “The science is catching up to the vision”, she said. Like Jo, Inui hopes that the field will successfully develop more scalable psychedelic-based therapies in the coming years.

Outside of the investment world, psychedelic advocates are hopeful, too.

Healing Breakthrough executive director Juliana Mercer told us that “momentum is on our side”, citing interest from Congress and the VA. She said that her group has been focused on establishing readiness in the wake of the rejection.

“I’m more encouraged today than I was a year ago”, she told us. “We’re no longer asking ‘if’”, she added, “we’re working with the VA and lawmakers on the ‘how,’ with training and readiness at the centre.”

Heroic Hearts Project founder Jesse Gould agrees. “I think that there is more momentum and bipartisan collaboration around these treatments than ever before”, he said.

Beyond the psychedelics bubble, other nonprofits are watching the field closely. The Anxiety and Depression Association of America, for example, said that it is “eagerly awaiting the results of pivotal, ongoing FDA regulated clinical trials”, and that it has had “numerous formal and informal discussions among its members about these developments.”

Panfil, the lobbyist, is ‘mostly positive’ in terms of his outlook for the field, but is hoping to see encouraging words from agency leaders turn into concrete action, including budget carve-outs for psychedelic research and finalised guidance from FDA on psychedelic trials.

Despite their critical tone last summer, members of that MDMA AdComm that we spoke to are cautiously optimistic.

One told us that they are “very optimistic about the future of psychedelic-based therapies”, noting that “they operate through novel mechanisms of action” and that the evolving dataset suggests they can be effective in the treatment of psychiatric disorders.

Still, they suggested that we “continue to rely on evidence based methods to systematically assess the safety and efficacy of these interventions to determine for whom and when they can provide optimal benefit at acceptable risk.”

Witczak, the consumer representative, is cautiously optimistic, too.

“The past year has reinforced both my hope and my caution”, she told us, citing encouraging signals from research into drugs like psilocybin. But, as with MDMA, she says, “the core issue isn’t just the potential, it’s also the execution.”

“Like other novel pharmaceutical treatments,” she continued, “psychedelics shouldn’t be marketed as a golden solution or quick fix; lasting outcomes require integration and skilled therapeutic support.”

The patient safety advocate also thinks the process revealed issues with FDA’s ‘framework’, which she says “isn’t built to regulate drug-assisted therapy where the therapy is integral to the treatment.” She believes that this poses an “opportunity for the FDA to build a new regulatory framework that fully integrates the therapy component.”

“My vote then, and now, is not about closing the door”, she told us. “It’s about making sure these issues are addressed so the therapy can succeed without preventable harm or backlash.”