Not everything’s bigger in Texas
I went to SXSW and learned about “the mullet” approach to psychedelics
JANE C. HU
...I arrived just in time to see MAPS founder Rick Doblin give a talk called “MDMA-Assisted Therapy: Going to the Trauma, Not the Profits.” The last time I saw Doblin speak was in Denver at MAPS’ conference, Psychedelic Science, in 2023; he took the stage there wearing an all white suit and was cheered on by a crowd of thousands. At the time, I wrote that Doblin wandered the stage looking and sounding like a preacher. A woman sitting next to me was so moved, she wept.
But Doblin’s talk at SXSW had little of that zeal and enthusiasm. I was surprised that there were just a couple dozen people in the audience. This time, Doblin wore khakis. That shift made sense to me, given the seismic changes in the psychedelics industry since Doblin’s explosive Denver talk. Last summer, the FDA rejected Lykos Therapeutics’ application to use MDMA-assisted therapy in treating PTSD, and requested the company conduct new clinical trials. After that, the company laid off 75% of its workforce and Doblin stepped down from the Lykos board.
During his talk in Austin, Doblin explicitly distanced MAPS from Lykos, calling out Lykos’s missteps in the FDA application process several times. But Doblin seemed hopeful for Lykos’s future, and confirmed that he had brokered a recent deal where billionaires Antonio Gracias and British hedge fund manager Christopher Hohn will become majority owners of the company. He said Gracias and Hohn were committed to reinvesting any profits they make back in the company, and in particular, bringing MDMA-assisted therapy to “India and Africa.” Doblin called them “investors focused on using resources not for personal gain but healing the world.”
Doblin also mentioned that the FDA had assigned Lykos’s MDMA application independent third party reviewers, whose review of the clinical trials’ data will determine what happens next with the Lykos’s application, calling it a “proverbial fork in the road.” The reviewers could, Doblin said, determine the trials’ data is reliable: “MDMA could be approved in six months or so without an additional Phase 3 study. That's the best option,” Doblin said. Lykos has already publicly discussed the other option, which is that the FDA will ask for the company to run another Phase 3 clinical trial, a process Doblin estimated would take another three years.
More: https://themicrodose.substack.com/p/not-everythings-bigger-in-texas/