The FDA's decision against granting approval to MDMA-assisted therapy for PTSD reflects concerns over clinical trial standards and the preparedness of MAPS in drug development.
Despite initial promising results, the FDA's rejection stems from doubts about the trial's design and methodology, which raised significant concerns about its credibility and implications.
While advocates decry the decision as detrimental to patients suffering from PTSD, the FDA's cautious approach underscores the need for rigorous scientific validation in psychedelic treatment.
The defeat for Lykos Therapeutics pivots on a critical evaluation of its clinical evidence, illustrating the intricacies involved in bringing psychedelic therapies to market.
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