[1][3] Rick Doblin, the founder and former chief executive of MAPS, has said that he wished that MDMA for PTSD could have been developed purely with philanthropic funding, but that this goal had failed.

[7] In June 2024, an 11-member FDA advisory panel of independent experts voted overwhelmingly against MDMA-assisted psychotherapy for PTSD.

[8][6][9][10] The leftist and anticapitalist psychedelic media organization Psymposia has been accused of inappropriately influencing the hearing and contributing to the rejection.

[3] Although the FDA had previously signed off on the phase 3 trial design in 2017, including notably the handling of placebo controls and agreeing to an inacive placebo control group,[10][6][9][12] the FDA ultimately decided to follow its advisory panel's recommendations and reject Lykos Therapeutics's NDA for MDMA-assisted psychotherapy for PTSD in August 2024.

[9] Psychopharmacology initially requested that MAPS PBC issue a correction by removing the relevant data from the analyses, which the company reportedly had complied with.

[12] On August 2024, also following the FDA's rejection, Lykos Therapeutics announced that it would lay off 75% of its workforce, which was about 100 employees, and that Doblin would resign from its board but remain with MAPS.

[17] In October 2024 and January 2025, despite setbacks, it was reported that Lykos Therapeutics had had productive new meetings with the FDA and was continuing to pursue approval of MDMA-assisted psychotherapy for PTSD.

[10] In January 2025, it was reported that Antonio Gracias, a billionaire investor, former Tesla board director, and Elon Musk ally, was attempting to take control of Lykos Therapeutics with $100 million in new investment and proposals to restrengthen its ties with MAPS towards the goal of attaining FDA approval of MDMA-assisted psychotherapy.