How the next psychedelics companies believe they can avoid Lykos’ fate

From start to finish, the many irregularities that led to FDA’s rejection of Lykos’ MDMA program are unlikely to be issues for other companies in the psychedelic space, argue the leading competitors in the space.

There’s no denying that the combination of high expectations and functional unblinding is a class-wide issue for psychedelics, but it doesn’t have to be an insurmountable one. The consequences of functional unblinding may have been especially problematic in the trials run by Lykos Therapeutics PBC, and in the end, the issue turned out to be only one among many with its submission. ...