The U.S. Food and Drug Administration asked Lykos Therapeutics, the company that applied for approval, to run more studies on using MDMA (better-known by the street names ecstasy and molly) in conjunction with therapy to treat patients with post-traumatic stress disorder. (The Logic)

Talking point: The decision follows advice in June from an FDA advisory committee that flagged a raft of concerns with Lykos’s application—from lack of data on the drug’s addictive potential to limitations in the structure of the clinical trial. Lykos said conducting another Phase 3 trial would take years, and it plans to ask the FDA to reconsider its position. The move could set back Canadian manufacturers and distributors, which have been at the forefront of the medical MDMA movement but worry regulators in other countries may take cues from the U.S. In a statement following the decision, Nicholas Kadysh, founder and CEO of Canadian MDMA manufacturer PharmAla, said his firm believes the FDA is “acting in good faith.” Still, he said, prudence should be balanced with the “vitally important patient need for novel PTSD treatments.”