Motley Fool Money You Can’t Patent LSD
Nov 23, 2024
In this discussion, Keith Speights, a Motley Fool contributor specializing in the psychedelic industry, shares insights on the evolving landscape of psychedelic stocks. He highlights the challenges investors face in this speculative market and elaborates on regulatory hurdles. The conversation touches on the complexities of conducting double-blind tests for psychedelics, as well as the key differences between the cannabis and psychedelic sectors. With companies like Compass Pathways navigating tough waters, the future holds both risks and potential for recovery.
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Psilocybin Trials
- Psilocybin clinical trials address safety, dosage, and efficacy, similar to other drug trials.
- Early results show promise, leading to larger phase 3 trials for therapies by Compass Pathways and Cybin.
Clinical Trial Phases
- Clinical trials have three phases: 1) Safety testing, 2) Safety, efficacy, and dosage, 3) Large-scale efficacy and safety confirmation.
- The FDA can grant accelerated approval in cases of high unmet medical need, requiring a confirmatory study after approval.
Regulatory Landscape for Psilocybin
- The FDA wants proof of efficacy and safety for psilocybin, focusing on preventing misuse and managing psychoactive effects.
- Psilocybin's Schedule I status, implying no medical use and high abuse potential, is being challenged legally.