Not admitted · Not a forecast
Rules 1.1.0 · as of 14 Sep 2026
Rick Doblin · Said 1 Dec 2016 · doblin-0049
Quote
Not a forecast
“While we’re not sure how to estimate the chances that the FDA will accept our two modifications—for Breakthrough Therapy Designation and to conduct one rather than two Phase 3 trials—we’re asking for the best outcome possible.”
On two requests submitted to FDA in October 2016: Breakthrough Therapy Designation and a single Phase 3 trial with the Phase 2 meta-analysis as confirmatory. Doblin explicitly declines to estimate the odds.
Descriptive, retrospective, or a statement of preference; no future state asserted.