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Amazing how well this holds. We should see some nice revs soon.
Bet this is trips by July
I owned GW back in the day and held a chunk at the buy out. I believe in what MNMD is doing and the fact they have a board member that seen GW through an acquisition makes me even more bullish.
This could be over 100.00 a share at an offer. I'm holding tight.
Still looking and digging. :)
This company will be one of the ones bought out. I am holding out for that because I don't think they will commercialize and distribute themselves. They now have on their board the same person that helped GWPH get bought out by Jazz Pharmaceuticals.
LSD is a game changer.
Hang in there.
For what...
...again...
Strange chart with all that volume months back. I have good chunk but surprised by the price action. Seems like they are making the right moves for a company with this type of share structure.
I really pegged this at least 2 or 3 pennies.
I agree, but with the FCM crap it is good that they just stay in touch with investors. I have hope hopes that they are bought out or will their own FDA approved product in 1-2 years.
MindMed First Quarter 2023 Financial Results and Business Update
today at 4:30pm EST
https://events.q4inc.com/attendee/995425624
Hang in there... this will ramp up soon with MDMA therapies being approved soon. ATAI and MNMD will be two of the big plays toward the end of the year when clinical trial data is released.
MNMD has an earnings call today as well. Just FYI.
$SWISF - Huge Cup & Handle + Bull Flag
Bone... will you start to believe me now...???
Is it time to sell in May and go away until 2024? :)
Odd... I did not get such letter. I knew they were moving to Schwab... but not closing my account.
Why would they sell them - I have TD and I am not concerned about this. Did you get a notice or something regarding this?
Agree. I have always felt good about Barrow. But agree the cleaner look will go a much longer way.
MindMed Sends Letter to Shareholders Highlighting Company’s Positive Momentum and Value-Enhancing Strategy
https://www.businesswire.com/news/home/20230502005568/en/MindMed-Sends-Letter-to-Shareholders-Highlighting-Company%E2%80%99s-Positive-Momentum-and-Value-Enhancing-Strategy
Files Definitive Proxy Materials in Connection with June 15, 2023 Annual Meeting
Board’s Nominees Possess Essential Pharmaceutical Industry, Capital Allocation and Corporate Governance Experience Needed to Drive Company’s Success at Pivotal Moment – With Two Key Clinical Readouts Expected Later This Year
Believes FCM’s Nominees Lack Relevant Experience and are Unqualified to Serve as MindMed Directors – Let Alone Take Control of the Company
Urges Shareholders to Protect Their Investment and Vote on the WHITE Proxy Card for ALL Six of the Board’s Nominees
Visit www.ProtectMindMed.com
MindMed Sends Letter to Shareholders Highlighting Company’s Positive Momentum and Value-Enhancing Strategy
MindMed Sends Letter to Shareholders Highlighting Company’s Positive Momentum and Value-Enhancing Strategy
MindMed Sends Letter to Shareholders Highlighting Company’s Positive Momentum and Value-Enhancing Strategy
May 02, 2023 08:00 AM Eastern Daylight Time
NEW YORK--(BUSINESS WIRE)--The Board of Directors (the “Board”) of Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), (NEO: MMED) (the “Company” or “MindMed”), a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders, today sent a letter to shareholders highlighting the importance of voting at its upcoming 2023 Annual Meeting of Shareholders (the “Annual Meeting”). By voting for the Board’s nominees, shareholders can support the significant progress that has been made under the current Board to achieve MindMed’s mission to deliver on the therapeutic potential of psychedelics and other novel candidates to address the significant unmet need in brain health disorders.
The Company also announced that it has filed its definitive proxy statement and WHITE proxy card with the U.S. Securities and Exchange Commission (“SEC”) in connection with its upcoming Annual Meeting to be held on June 15, 2023.
The Company has launched www.ProtectMindMed.com to keep shareholders up to date on key developments leading up to the Annual Meeting.
The full text of the Board’s letter to shareholders, which can be viewed and downloaded here, follows:
May 2, 2023
Dear Fellow Shareholders,
Thank you for your investment in MindMed. Your vote at the Company’s 2023 Annual General Meeting of Shareholders, scheduled for June 15, 2023, is critically important this year. Voting is now open, and we are asking you to elect the directors you believe are best qualified to lead the Company through a pivotal period in our lifecycle, as we progress key Phase 2 trials in MM-120 and initiate our first sponsored clinical trial of MM-402.
Our mission is to deliver on the therapeutic potential of psychedelics and other novel candidates to address the significant unmet need in brain health disorders. We have overseen tremendous progress toward this goal, and your current Board and management team are creating a foundation for the Company that will generate sustainable value for all shareholders. Your support of the Company’s highly qualified director candidates is essential to ensure this progress continues.
FCM MM Holdings, LLC (“FCM”), an entity affiliated with Jake Freeman, Scott Freeman and Chad Boulanger, has nominated four director candidates who we believe are unqualified to serve on your Board. FCM is waging a proxy contest to take control of the Company despite only owning a small percentage of our outstanding shares and failing to provide any realistic strategic plan for MindMed.
We believe that allowing FCM to harm the Company’s current strategy and management team – who have been successfully executing our plan under your Board’s oversight – would put your investment at risk.
We strongly urge you to protect your investment by voting today on the WHITE proxy card FOR the election of the Board’s highly qualified nominees – Chief Executive Officer Robert Barrow, Dr. Suzanne Bruhn, Dr. Roger Crystal, Andreas Krebs, Chair Carol A. Vallone, and new candidate David W. Gryska, a 35-year industry veteran who has served as Chief Financial Officer of two S&P 500 pharmaceutical companies – and WITHHOLD on FCM’s inferior nominees.
YOUR BOARD IS OVERSEEING A WELL-DEFINED PLAN TO CREATE VALUE BY BRINGING IMPORTANT NEW TREATMENTS TO PATIENTS – WE URGE YOU TO STAY THE COURSE AT THIS CRITICAL MOMENT
Since Robert Barrow took on the role of CEO in mid-2021, we have made decisive and comprehensive changes that are essential to the long-term success of our organization. We have recruited an efficient and execution-oriented team with deep experience in the successful research, development and commercialization of brain health treatments.
We have also built an internal organizational infrastructure – which incorporates high standards of compliance and financial controls – to support our operations as a publicly traded pharmaceutical company. These changes have transformed MindMed from a nascent public company with a single product candidate to a high-functioning organization in a position of strength as we enter a critical period for our R&D pipeline.
By progressing this strategy to develop our diversified pipeline of clinical programs, we are on track to build a world-class fully integrated pharmaceutical organization to create long-term value for our shareholders. We are also well capitalized, with cash on hand of $142.1 million as of the end of 2022 – sufficient to fund the Company’s operations beyond our key development milestones in 2023 and into the first half of 2025.
MindMed is at a pivotal inflection point – with clinical readouts on our two lead product candidates expected this year:
Our Phase 2b study of MM-120 for the treatment of Generalized Anxiety Disorder (“GAD”), and
Our Phase 2a proof-of-concept trial of repeated low-dose MM-120 in ADHD.
We also plan to share preclinical results demonstrating the potential of MM-402 in autism spectrum disorder and to initiate our first sponsored clinical trial of MM-402.
Our research with patients and healthcare practitioners in the U.S. and Europe indicates that there is significant demand for a new class of drugs that can offer faster, more effective and longer lasting benefits for patients with GAD. This represents a tremendous potential addressable market for our therapies.
We have also pursued a robust strategy to maximize and protect the value of our intellectual property: our patent portfolio includes 26 pending U.S. applications and 12 pending Patent Cooperation Treaty applications. These include applications covering compositions, dosing, dosage formulations and methods of treatment, among others, with projected expiration dates beginning in 2041.
Our current management team and R&D leaders – all of whom have been hired since Scott Freeman left the Company – are the inventors of a majority of our pending patents, in particular those that we believe are most significant for market protection of our lead product candidates. MindMed currently owns and retains all clinical data and manufacturing rights for MM-120, and we are aggressively protecting and expanding our intellectual property portfolio.
Don’t simply take our word for it – third-party analysts agree that our strategy is working:
“We continue to see shares undervaluing the opportunity for a novel mechanism to treat GAD even with conservative assumptions around patent life and market uptake, and look to additional derisking events this year.” – RBC Capital Markets, March 9, 2023
“Despite competition from several emerging psychedelic biotechs, we believe MNMD is a well-capitalized leader poised to disrupt the large, growing mental health market.” – Oppenheimer, August 25, 2022
“We are reiterating our Buy rating and $21 price target on MindMed following the release of clinical data with LSD in major depressive disorder.” – EF Hutton, April 14, 2023
WE HAVE A WORLD CLASS BOARD – WITH EXACTLY THE RIGHT EXPERIENCE – THAT IS PURSUING SHAREHOLDERS’ BEST INTERESTS
Our Board’s diverse set of nominees are six highly qualified individuals, five of whom are independent. They collectively possess significant senior executive and public company director experience and have relevant backgrounds and expertise in the areas critical to MindMed’s success: drug development and commercialization; financial management and capital allocation; and corporate governance and compliance.
Since June 2021, we have completed a comprehensive and proactive effort to refresh our Board to ensure it has the right mix of experience and expertise to execute on our strategic objectives. In 2021, the Company recruited Carol Vallone (Chair of the Board of Trustees of the #1 hospital for psychiatry among all hospitals nationwide) and Andreas Krebs (former Executive at Wyeth) to join our Board – both of whom are experienced executives with track records for success in business launches to exits, capital raises, extensive leadership and governance experience in pharmaceuticals and healthcare, and strong histories of supporting value-creating organizational growth. In 2022, we added Drs. Roger Crystal and Suzanne Bruhn, who are both accomplished executives and directors of successful pharmaceutical and biotechnology companies, and bring decades of experience in leading clinical research, regulatory strategy, commercialization and partnerships.
Our additional nominee for election at this year’s Annual Meeting, David Gryska, will further strengthen our Board. Mr. Gryska is a respected life sciences professional with over 35 years of experience as a senior financial executive, including as Chief Financial Officer of two S&P 500 companies – Incyte (NASDAQ: INCY) and Celgene Corp. He currently serves as a board member at Seagen Inc. (NASDAQ: SGEN), which has agreed to be acquired by Pfizer Inc. (NYSE: PFE) for $43.0 billion, and Forte Biosciences, Inc. (NASDAQ: FBRX). He previously served as a board member of GW Pharmaceuticals plc prior to its acquisition by Jazz Pharmaceuticals (NASDAQ: JAZZ) for $7.2 billion in 2021 and of Aerie Pharmaceuticals prior to its acquisition by Alcon (NYSE: ALC) for $750.0 million in 2022.
The Company’s slate of directors represents a 100% refreshment of the Board since Mr. Barrow took on the role of CEO in mid-2021.
DO NOT SUPPORT ANY OF FCM’S CANDIDATES – THIS WOULD RISK YOUR INVESTMENT BY POTENTIALLY UNDOING OUR SIGNIFICANT PROGRESS SINCE 2021
FCM has not made a convincing case that any change is needed – let alone the replacement of a majority of the Board. Further, FCM has not put forth a coherent plan for how its nominees would enhance value for MindMed’s shareholders.
Consistent with the Board’s commitment to constructive shareholder engagement, members of the Board and management have met with Jake Freeman, Scott Freeman and Chad Boulanger numerous times since August 2022 to evaluate FCM’s perspectives on the Company and its strategic direction. In these discussions it became abundantly clear that FCM does not understand MindMed’s business – which has significantly evolved since Scott Freeman left the Company in 2020 – or the associated regulatory processes.
The ideas FCM floated in its August 2022 “Value Enhancement Plan” – which it still embraces – as well as thoughts it has put forth haphazardly on social media, would destroy shareholder value. These proposals reflect a pronounced misunderstanding of FDA drug approval processes, an ignorance of the capital allocation and financing needs of a company at MindMed’s growth stage, and a disregard for what is in the best interests of all shareholders. To highlight two examples:
There is no credible basis for FCM’s misplaced claim that MindMed could skip its Phase 2 study for MM-120 and go directly to Phase 3. When pressed by us in meetings, Scott Freeman and FCM’s other representatives could not provide any substantive responses to our questions about their plan to skip Phase 2. FCM appears to lack familiarity with both the complex regulatory regime governing our clinical programs and the basics of the drug development process. Their claims may be relevant to oncology products (the only therapeutic area in which FCM candidates have worked) but are not relevant in the development of treatments for major market psychiatric disorders.
FCM’s approach to cost cutting and program investments is misguided and would be highly destructive to the business. FCM’s proposed “slash and burn” approach ignores the key drivers of value for a clinical stage biotech company. The path for MindMed to create shareholder value and benefit patients is to ensure that we have the resources needed to retain top talent and successfully execute on our clinical development plan and go-to-market strategy. Over the past two years, we have attracted one of the top rosters of talent in our sector, and we continue to operate as an efficient and high-functioning team. We take a highly disciplined approach to expenditures: relative to our two largest and closest peers, we spend materially less in absolute terms, with less of that money allocated to SG&A.
In an effort to avoid a costly and distracting proxy contest, we have presented FCM with multiple constructive proposals, including offering to place a mutually-agreed upon independent director on the Board. Unfortunately, FCM has rejected all of our attempts to find common ground. FCM’s unprofessional public communications are not indicative of a mature or experienced approach to business. This is not a group that shareholders should want to have any representation on the MindMed Board.
FCM’S NOMINEES ARE UNQUALIFIED TO SERVE ON THE BOARD
After careful consideration of FCM’s intended nominees, the Board has concluded that they do not – individually or collectively – possess relevant industry background or experience that would be additive, especially in comparison to the Board’s proposed slate of directors. As a result, the Board strongly believes that it is in the best interests of all shareholders to NOT VOTE FOR ANY OF FCM’s CANDIDATES to be elected.
None of the FCM nominees has ever served on the board of a public healthcare company or as an executive of a public healthcare company (other than Scott Freeman, who held an executive role for less than a year at MindMed when it was a nascent organization). In fact, the only public company director experience of any of the nominees was at a ~$21 million market cap e-paper display company listed in Canada only. Despite FCM’s overinflated touting of their qualifications, these nominees lack essential experience or expertise in key areas of focus for the Company’s success (see Table 1).
Table 1
MINDMED CANDIDATES
Significant experience overseeing research, development and commercialization of pharmaceutical products
Extensive public company and corporate governance experience in the pharmaceutical / healthcare industry
Successfully overseeing the execution of the Company’s strategy to bring brain health treatments to market and build a foundation to deliver shareholder value
Deserving of your vote on the WHITE proxy card
?
?
?
?
FCM CANDIDATES
No credible strategic plan for the Company
No significant public healthcare company board experience or gender diversity
No meaningful experience overseeing the commercialization of pharmaceutical products or successful clinical trials
NOT deserving of your vote
? ? ? ?
***
MindMed’s Board is committed to delivering sustainable long-term value creation for all shareholders. This is a critical period of execution for the Company, and allowing FCM’s inexperienced and unqualified nominees to be elected to the Board – let alone take control of it – would risk substantial and permanent value destruction. We ask that you act to protect your investment by voting FOR ALL of the Board’s recommended nominees, voting WITHHOLD on FCM’s nominees and discarding any proxy materials you receive from FCM.
Sincerely,
The MindMed Board of Directors
VISIT WWW.PROTECTMINDMED.COM FOR MORE INFORMATION
Due to new U.S. federal rules requiring us to list FCM’s nominees in addition to the Board’s nominees, your WHITE proxy card this year has more names on it than the six directors to be elected. The inclusion of FCM’s nominees on our WHITE proxy card does NOT mean the Board endorses them
Vote TODAY on the WHITE proxy card FOR all six of the Board’s nominees, WITHHOLD on FCM’s nominees, and FOR the other proposals recommended by your Board
You can help reject FCM’s efforts to take control of the Board by voting WITHHOLD on FCM’s nominees and discarding any blue proxy cards and materials you may receive from FCM
Proxy materials will be distributed by banks, brokers and other nominees in the coming days. Shareholders will receive proxy materials directly via the preferred method, hard copy or email, specific to each shareholder’s account. Shareholders that do not receive proxy materials over the next week, please contact your broker and request the WHITE voting control number or contact Morrow Sodali with questions.
If you have any questions, or need assistance voting your shares, please contact the firm assisting us in the solicitation of proxies:
Morrow Sodali LLC
509 Madison Avenue, Suite 1206
New York, NY 10022
Banks and Brokers Call: (203) 658-9400
Shareholders Call Toll Free: (800) 662-5200
Email: MNMD@investor.morrowsodali.com
About MindMed
MindMed is a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders. Our mission is to be the global leader in the development and delivery of treatments that unlock new opportunities to improve patient outcomes. We are developing a pipeline of innovative product candidates, with and without acute perceptual effects, targeting neurotransmitter pathways that play key roles in brain health disorders.
MindMed trades on NASDAQ under the symbol MNMD and on the Canadian NEO Exchange under the symbol MMED.
Just seen this. Hang on folks. It's coming.
Great time to get back in. Sector is going to heat up. ATAI as well.
Nice bull flag! Let's Go!
As soon as it hits Pink smacking it hard
Video - MindMed CEO Explains New Vision For Company - TDR Exclusive
https://www.youtube.com/watch?app=desktop&v=E_yjQMvIX6c
Video - MindMed update on major depressive disorder data: Rob Barrow, CEO
https://www.edisongroup.com/edison-tv/mindmed-update-on-major-depressive-disorder-data-rob-barrow-ceo/32225/
MindMed is a clinical-stage US biopharmaceutical company aiming to leverage psychedelic medicines to target life-debilitating mental health conditions such as anxiety, ADHD and autism. Its most advanced clinical programmes are investigating the use of LSD D-tartrate (MM-120) for treating generalised anxiety disorder (GAD) and attention-deficit hyperactivity disorder (ADHD). The Phase IIb GAD trial is a randomised dose-finding study that will recruit up to 200 patients and is expected to deliver top-line results in H223. The Phase IIa proof-of-concept study in ADHD will assess the safety and efficacy of low-dose MM-120 as treatment for ADHD in adults, with readouts anticipated in H223. Additionally, the company will initiate a Phase I study in 2023 investigating R-MDMA for treating autism spectrum disorder. MindMed is also looking to use digital platforms to provide scalable, accessible and safe psychedelic treatment solutions to patients, overcoming resourcing constraints faced by healthcare providers and promoting adoption.
In this video, Rob Barrow, MindMed Chief Executive Officer, provides an update on the recently released positive phase II top-line data addressing major depressive disorder.
Holding up amazingly well. Should get more before the next leg up. :)
It brought it :)
Hmmm... thinking I should buy more here before the burst.
Very nice 2 days here.
lol! That just means it will take AI to make everything better!
I meant to say the cannabis sector got nothing on AI!!!
I was blown away by it... ran a few tests with it... super impressed.
I mean... this one is just like reading the Sunday comics
I don't think so...
I keep buying... haven't stopped :)
Let me say this... I just played around with Chat GPT... going to be honest. I thought cannabis was big... AI as a whole got nothing on that sector from back in 2014.
LSD to treat severe anxiety? Cleveland Clinic at forefront of psychedelic research
https://www.cleveland.com/metro/2023/04/lsd-to-treat-severe-anxiety-cleveland-clinic-at-forefront-of-psychedelic-research.html
Published: Apr. 15, 2023, 5:30 a.m.
LSD study Cleveland Clinic
Dr. Brian Barnett, a physician with the Center for Adult Behavioral Health at Cleveland Clinic – Lutheran Hospital, adjusts a monitor in the room where participants in an LSD study will receive doses of the drug, or a placebo. LSD may be able to help the large numbers of American adults diagnosed with a mental health disorder. Julie E Washington, cleveland.com
Julie Washington, cleveland.com
CLEVELAND, Ohio — The Cleveland Clinic is in the vanguard of a new era of research into psychedelic medicine.
The Clinic is the only Ohio site participating in a national study looking at whether LSD, administered in a controlled setting, can help people with severe anxiety. The disorder is a risk factor for suicide.
If the results of the Clinic’s trial and others like it across the country are positive, LSD could be approved as a psychiatric treatment within the next five years, said Dr. Brian Barnett, a physician with the Center for Adult Behavioral Health at Cleveland Clinic – Lutheran Hospital. He is running the Clinic’s LSD study, and is co-director of the hospital’s Treatment-Resistant Depression Clinic.
“Psychedelics are the most powerful psychoactive drugs that we have,” Barnett said. “We believe that if LSD is used appropriately by trained personnel in a therapeutic setting, it can be extremely beneficial.”
Starting this month, study participants will go to Lutheran to receive a single dose of LSD or a placebo, as part of the randomized, placebo-controlled trial, while under observation, Barnett said. They may notice that colors look more intense or that they are able to hear music in more detail than normal.
Small doses of LSD loosen up the patient’s consciousness and make them more readily able to discuss unconscious thoughts. Larger doses induce what’s called a mystical experience, during which people feel connected with the universe and as if they have experienced the divine.
LSD may be able to help the large numbers of American adults diagnosed with a mental health disorder, said MindMed CEO Robert Barrow. MindMed, which is sponsoring the study at the Clinic and 19 other sites, investigates the therapeutic potential of psychedelic drugs for psychiatry, addiction, pain and neurology.
Psychedelic drugs have the unique ability to show clinical benefits quickly while also maintaining those benefits for up to a year after only a few doses, Barrow said.
“In a field that has seen little meaningful innovation in decades, this represents a potential revolution in the treatment landscape for the many patients suffering from conditions like generalized anxiety disorder,” Barrow said.
Those interested in joining the study can follow this link.
Discovered in 1943, LSD — or lysergic acid diethylamide — was the subject of numerous scientific studies into its psychiatric use during the 1950s and 1960s. But its association with drug culture, and eventual criminalization, slowed its use in research.
“That history included over 20 studies in hundreds of patients with anxiety, depression and other neurotic illness, with consistent remarkable treatment responses,” MindMed’s Barrow said.
“Fortunately, we have seen a resurgence of research with LSD and the psychedelic drug class over the past several years, and this modern research has confirmed those earlier findings,” Barrow said.
The Cleveland study is among one of the first industry-sponsored trials involving LSD in about 50 years, the Clinic’s Barnett said.
“There’s really just so much that we don’t know,” Barnett said. “Research has been shut down for so long that we’ve had to start at the beginning. But there are a lot of very positive signs from research decades ago.”
Comfortable room guides LSD experience
A cozy room — decorated with cushioned chairs, a rug and pillows in soothing blues and taupes — has been set up at Lutheran especially for people taking LSD as part of the trial.
Study participants lie on a couch, don eyeshades and listen to a curated music playlist after ingesting LSD or a placebo. It is a double-blinded trial, which means that neither the caregivers nor the patient know who is receiving a drug or a placebo.
Participants can get 20 micrograms, 50 micrograms, 100 micrograms, 200 micrograms or a placebo.
Some people experience anxiety in the first hour after taking LSD. Facilitators use breathing exercises and guided imagery to help bring them back to a therapeutic response, Barnett said.
Study participants currently taking medications such as antidepressants must be willing to taper off those medications over a few weeks as part of the trial, he said. This allows researchers to evaluate the effectiveness of LSD without the assistance of other psychiatric medications.
Study participants also need healthy hearts, because psychedelics raise blood pressure and heart rates.
Very rarely, psychedelic drugs can unmask bipolar or schizophrenia in patients who have a family history of those disorders, but who have not yet had symptoms. People with family histories of bipolar disorder or schizophrenia are excluded from the study, Barnett said.
After receiving LSD or a placebo, study participants stay at Lutheran for at least 12 hours under observation, he said. Patients have nine visits to Lutheran total for the study, including the one-time LSD dosing session. There are six follow-up visits after the dosing session to evaluate the patients’ anxiety. These occur weekly to every four weeks, with the last one occurring 12 to 17 weeks after the dosing session.
“We think that LSD will be shown to be able to be safely administered in a supportive setting in a hospital environment,” Barnett said.
Clinic LSD study
“I think that we're going to see a fundamental shift in the way that psychiatry is practiced over the next five to 10 years, with psychedelics becoming a mainstay of treatment for many patients,” said Dr. Brian Barnett of the Cleveland Clinic. He is running the Clinic’s LSD study investigating the drug as a treatment for severe anxiety.Julie E Washington, cleveland.com
LSD: ‘three scary letters’ or beneficial drug?
There was a time when LSD was part of normal psychiatric treatment, especially on the East and West coasts, Barnett said.
Some LSD studies suggested that it helped patients with alcohol use disorder by helping them achieve a new self-image and willpower, according to a 2015 article published in the Canadian Medical Association Journal.
Another study published during this era, suggested that anxiety related to a recent cancer diagnosis decreased in patients who were treated with LSD.
But as LSD became linked with 1960s counterculture and drug abuse — although most experts say it is not addictive — the drug was made illegal.
“When I was growing up, LSD were probably the three scariest letters in the English language,” the Clinic’s Barnett said.
Currently, LSD is classified as a Schedule 1 substance, MindMed’s Barrow said. This means it is considered to have a high potential for abuse and no currently accepted medical use.
But attitudes toward LSD are changing. Oregon became the first U.S. state to decriminalize the possession of small amounts of LSD in 2020.
MindMed is conducting other trials to test LSD’s safety and effectiveness in treating attention deficit hyperactivity disorder. Other investigators are looking into the use of psilocybin, or magic mushrooms, to treat patients who are in hospice.
“The best way to get a drug rescheduled from Schedule 1 is to provide evidence of an accepted medical use,” MindMed’s Barrow said. If LSD is approved for patient use, it would probably be delivered in a clinical setting under supervision, Barrow said.
Because LSD is illegal, the Clinic had to meet Drug Enforcement Agency regulations before it could join the study. The drug is stored in a locked refrigerator that’s bolted to the floor, in a room monitored by surveillance cameras. Staff underwent background checks.
“It took us more than a year working behind the scenes with the company, the FDA and the Drug Enforcement Agency to get this off the ground,” the Clinic’s Barnett said.
These regulations are well intentioned, but they also make psychedelic research hard to do, Barnett said. Advocacy groups are working with Congress to reduce these bureaucratic barriers to further research.
“Having to go through months — even years — of paperwork is really what slows down the efforts by companies to bring these drugs to market as medications,” Barnett said.
The Clinic began recruiting for the MindMed study in February, with plans to treat its first study participants this month. The hospital system hopes to enroll at least 10 participants in the phase 2 study.
The Clinic’s Barnett hopes this study leads to the creation of a larger psychedelic therapy research community in Cleveland.
“I think this is a valuable opportunity for the scientific community (in Cleveland) to really catch up and participate in the psychedelic renaissance,” he said. “I think there’s going to be some significant opportunities to develop new treatments that could be potentially life-changing for patients.”
This is big news. They also added a new person to the group that understands mergers. Going to be an interesting year. Hang tight.