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Rules 1.1.0 · as of 14 Sep 2026

Rick Doblin · Said Aug 2024 · doblin-0267

Quote

“Appeals, though the outcomes are uncertain, are in process for the FDA's rejection and the retraction of the papers. FDA has called for a third Phase 3 study, and if Lykos is unsuccessful in its appeal, potential FDA approval is now at least two years away, possibly more.”
· FDA Decision, Redoubling of MAPS Efforts, and Lykos Board Resignation - MAPS · own post

In his open letter to the MAPS community after the August 2024 complete response letter, Doblin says appeals of the FDA rejection are under way, calls the outcomes uncertain, and gives the consequence if the Lykos appeal fails: approval at least two years away.

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