New Approaches to Psychedelic Clinical Trials Could Overcome Regulatory Hurdles
Lykos Therapeutics was earlier this year denied approval for their MDMA formulation developed to treat post-traumatic stress disorder. The FDA advisory panel that rejected the application cited various issues as their basis, including sexual misconduct during the clinical trials, concerns about the drug’s potential for abuse, and a failure to submit data requested. Soon after, Lykos let go of over 70% of its workforce. Following these developments, Compass Pathways PLC (NASDAQ: CMPS) recently announced that it’d be delaying its phase III trial results reporting timeline to make certain that it could endure scrutiny associated with trial blinding. Compass Pathways, which…






