On June 4, a panel advising the FDA voted against Lykos Therapeutics, questioning the effectiveness of MDMA-assisted therapy for PTSD and stating that the risks of MDMA outweigh its benefits.
Despite the advocacy work by MAPS for psychedelic therapy, the FDA panel's decision on Lykos came as a surprise, casting doubts on the safety and efficacy of the treatment.
The rejection by the FDA panel was termed a 'very bad day for Lykos' by Mason Marks, reflecting the setback faced by the company in gaining approval for its MDMA therapy.
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