Clinical ConductClinical 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.
Evidence Report IssuesICER’s initial draft evidence report pointed to multiple concerns and controversies related to Lykos’ MDMA-assisted therapy, including functional unblinding and bias.
Regulatory ConcernsFDA had also asked Lykos to collect more data on AEs and abuse potential during phase 3, which wasn't captured to FDA's satisfaction.