At Bonaventure Equity, we aim to bring you perspectives from the front lines of investing in controlled substances, delving beyond the headlines in this dynamic field.
This week, another significant event unfolded that warrants deeper analysis.
Overview
On Tuesday, an FDA Advisory Panel voted NO on supporting the Lykos (MAPS) MDMA PTSD treatment. This decision has been widely perceived as a major setback for psychedelic therapy.
However, we see it differently and we believe it’s important to consider why.
- Overview
- Hot Take
- Key Reasons For The NO Vote
- Positive Aspects
- Implications For Investors
- Conclusion
- Some Of The Headlines We’re Reading
- Be Part Of The Conversation in Tuesday’s Webinar
Hot Take
This advisory committee meeting is not the final FDA ruling. When the FDA requests an advisory panel review, it often indicates concerns about the trials requiring expert analysis. This does not mean that Lykos won’t eventually gain approval; it just means the path will be longer. The reasons for the no vote could ultimately be addressed.
Key Reasons For The NO Vote
- Risk-Benefit Concerns: There have been disturbing cases of patient abuse and misconduct in this trial, and it’s reassuring that these concerns are being considered in the FDA’s review. The panel highlighted flaws in the clinical research, including a lack of diversity and missing follow-up data.
- Psychotherapy Regulation: MAPS committed to an MDMA-assisted therapy model, but the FDA does not regulate psychotherapy. This model, while meritorious, is not scalable or manageable from an investment perspective.
- Data Concerns: The trial lacked crucial physiological and psychological data and couldn’t compare with a placebo due to the nature of MDMA. Despite compelling positive effects reported by patients, the evidence was insufficient
Positive Aspects
The committee members emphasized the importance of this work for veterans and patients. They acknowledged the promise shown by the studies but could not recommend approval due to the reasons mentioned.
Implications For Investors
This decision is not a setback for psychedelics.
We don’t consider MDMA a psychedelic like psilocybin. The FDA’s serious approach to this hearing provides invaluable insights for other companies seeking FDA drug approvals for psychedelics.
Conclusion
The path forward for MDMA therapy may be challenging, but the work being done is crucial. We remain committed to investing in innovative therapies that can transform lives.
Some Of The Headlines We’re Reading
Here are a few of the headlines:
- nature.com: MDMA therapy for PTSD rejected by FDA panel
- npr.org: FDA advisors reject MDMA therapy for PTSD, amid concerns over research
- science.org: In a setback for psychedelic therapy, FDA advisers vote against medical use of ecstasy
- scientificamerican.com: MDMA Therapy Is Rejected by FDA Panel
- psychedelicalpha.com: FDA Advisory Committee Reviews MDMA-Assisted Therapy for PTSD
Be Part Of The Conversation in Tuesday’s Webinar
Join us this Tuesday for a live webinar on this topic. We’ll explore how we are investing in these pivotal times and for unique perspectives on the investment strategies, scientific advancements, and regulatory changes transforming the pharmaceutical landscape in the face of rescheduling:
Join the Conversation: BVE Insights Webinar
How We Are Investing: Rescheduling & The Future of Medicine
June 11, 2024 at 4 pm ET
Join us to learn about:
- Our investment thesis, portfolio, and opportunities.
- The scientific advancements and research potential being driven now that rescheduling is happening.
- What’s actually happening in DC.
- How you can best position yourself as an investor in the current landscape.
Register now (or catch the replay)
