Clinical PracticesClinical conduct concerns related to psychotherapy, as well as concerns/risk related to the lack of standardization of active treatment sessions, have raised some concerns for other psychedelic products including MM120.
Regulatory IssuesFDA had also asked Lykos to collect more data on AEs and abuse potential during phase 3, which wasn't captured to FDA's satisfaction; MindMed can learn from this.
Research And DevelopmentICER’s initial draft evidence report pointed to multiple concerns and controversies related to Lykos’ MDMA-assisted therapy, including functional unblinding and bias.