Chapter
FDA Approval and Special Protocol Assessment Process
1:23:15 - 1:29:18 (06:02)
The speaker discusses their agreement letter from the FDA's special protocol assessment process and the success of their phase three design. They are bound to approve the drug if they receive statistical evidence of efficacy and encounter no new safety issues.
Clips
Researchers conducted a phase three study on a repurposed 30-year-old drug to help people with PTSD sleep without nightmares but they faced failure and lost over a hundred million dollars in expenses.
1:23:15 - 1:24:34 (01:18)
Summary
Researchers conducted a phase three study on a repurposed 30-year-old drug to help people with PTSD sleep without nightmares but they faced failure and lost over a hundred million dollars in expenses. However, the study ended up being successful and met the expected effect size for the drug.
ChapterFDA Approval and Special Protocol Assessment Process
Episode#440: Rick Doblin — The Psychedelic Domino That Tips All Others
PodcastThe Tim Ferriss Show
The speaker discusses the FDA approval and special protocol assessment process for phase three studies, including the agreement letter that legally binds the FDA to approve the drug if statistically significant evidence of efficacy is found and there are no new safety problems.
1:24:35 - 1:27:11 (02:36)
Summary
The speaker discusses the FDA approval and special protocol assessment process for phase three studies, including the agreement letter that legally binds the FDA to approve the drug if statistically significant evidence of efficacy is found and there are no new safety problems.
ChapterFDA Approval and Special Protocol Assessment Process
Episode#440: Rick Doblin — The Psychedelic Domino That Tips All Others
PodcastThe Tim Ferriss Show
The donations for psychedelic research are not just coming from tie-dye wearing hippies, but also from influential people like the Rockefellers and George Soros who are supporting possible treatments for PTSD and other disorders.
1:27:11 - 1:29:18 (02:06)
Summary
The donations for psychedelic research are not just coming from tie-dye wearing hippies, but also from influential people like the Rockefellers and George Soros who are supporting possible treatments for PTSD and other disorders.