- The design of Vanda's primary Phase III study changed numerous times, including a complete replacement of the primary endpoint just one month before study results were announced.
- The replacement primary endpoint installed to assess Tasimelteon's benefit was created by Vanda and has never been used before in sleep-drug clinical trials, nor was it endorsed by the FDA.
- Vanda was forced to cut in half the patient enrollment into the Tasimelteon clinical trials because totally blind patients with non-24 could not be identified. Even then, Vanda was only able to enroll patients by stretching the clinical definition of non-24.
- Tasimelteon was only able to demonstrate a benefit for non-24 patients by combining data from two phase III studies. Despite Vanda's claims to the contrary, the phase III studies may have actually failed on their own.
Washington, DC Law Firm Finkelstein Thompson LLP Investigates Vanda Pharmaceuticals, Inc.
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