FDA has issued a Complete Response Letter (CRL) to Lykos Therapeutics regarding its New Drug Application (NDA) for MDMA-assisted therapy in PTSD, meaning the agency is not prepared to approve it at this time.The letter is not a complete surprise to industry insiders or Lykos itself, who had been bracing for a negative verdict from the agency amidst a number of negative appraisals in recent months.
