FDA gives thumbs down to MDMA for now, demanding further research

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.