After more than three decades of planning and a $250 million investment, Lykos Therapeutics' application for the first psychedelic drug to reach federal regulators was expected to be a shoo-in. Lykos, the corporate arm of a nonprofit dedicated to winning mainstream acceptance of psychedelics, had submitted data to the Food and Drug Administration showing that its groundbreaking treatment for post-traumatic stress disorder -- MDMA plus talk therapy -- was significantly more effective than existing treatments.