throwaway_ok2 on August 24, 2024 1:31 am To add clarifying information: -this is the independent advisory panel vote, the actual FDA decision is expected mid-August -the advisory panel vote was specific to Lykos’ 2 studies and concerns were known and reported on ahead of the vote -there were 4 areas of concern (1) inadequate blinding (2) cardiovascular risk (3) potential therapist misconduct (4) inadequate investigation of dependence risk Vote was 9-2 against effectiveness, 10-1 against benefits outweighing risks. In other words, not close.
1 Comment
To add clarifying information:
-this is the independent advisory panel vote, the actual FDA decision is expected mid-August
-the advisory panel vote was specific to Lykos’ 2 studies and concerns were known and reported on ahead of the vote
-there were 4 areas of concern
(1) inadequate blinding
(2) cardiovascular risk
(3) potential therapist misconduct
(4) inadequate investigation of dependence risk
Vote was 9-2 against effectiveness, 10-1 against benefits outweighing risks. In other words, not close.