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Dear colleague,
Today, I want to discuss the FDA's recent decision to reject Lykos' MDMA application for PTSD treatment =E2=80=94 a development that has sparked significant debate within the psychedelics community.
The news
The FDA rejected Lykos' application on Friday of last week, issuing a Complete Response Letter that detailed concerns about the study's design and the need for additional evidence before approval.
Why it matters
The rejection is a pivotal moment in the psychedelic medicine landscape, emphasizing the importance of patient safety and rigorous research standards.
Between the lines
Despite the rejection, the FDA's encouragement to continue Phase 3 trials shows a commitment to further research, indicating that MDMA's potential has not been dismissed.
Concerns
Issues such as data integrity, participant ethics, and the study=E2=80=99s design underscore the necessity of conducting careful, ethical research in advancing psychedelic treatments.
Our stance
While this decision might be seen as a setback, we view it as a crucial step toward ensuring the safety and effectiveness of psychedelics in medical treatments.
We support the FDA's decision as it aligns with our commitment to safe, evidence-based therapeutic advancements.
And, while we recognize the urgency in treating PTSD, we believe in prioritizing rigorous research for the long-term credibility of psychedelic therapies.
Learn more here. And stay tuned right here for details about the webinar below:
WEBINAR | Understanding the FDA's Rejection of MDMA for PTSD Treatment
August ?, 2024
All of this is unfolding in real time.
Join me, the BVE team, and leading regulatory and pharmaceutical experts for a BVE Insights Webinar and Q&A on DATE at TIME EST.
Watch this space for registration details.
Meanwhile let me know your thoughts and stay tuned with our BVE Insights.
Warm regards,
Ross.
Ross O'Brien
Founder & Managing Partner
Bonaventure Equity, LLC
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