The CRL goes on to suggest that Lykos conduct a new clinical trial in order to address these issues, which it says should focus on: Demonstrating durability of effect Minimising potential for bias Adequately characterising the safety of MDMA The agency provides more specific guidance for each of those broad areas of focus. It also recommended that Lykos “consider an …
Read More »BREAKING: FDA Publishes Lykos Therapeutics’ MDMA Complete Response Letter (CRL)
