Testimony to the FDA Peripheral and Central Nervous Systems Drugs Advisory Committee on Tasimelteon for the Treatment of Blind Persons with Non-24 Hour Sleep Disorder

View the presentation (PDF).

View the press release.

Approval of tasimelteon, given the magnitude of post-hoc changes to the clinical trial protocol, timed so close to the end of data collection, would set an ominous precedent for future new drug development programs.