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.
Investment RisksKey risks to the investment thesis include possible failure of MM120 in Phase 3 trials, new safety issues, regulatory setbacks, competitive pressures, payer pushback, and the risk of psychedelics being marginalized due to adverse publicity.
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.