Shareholder law firm Finkelstein Thompson LLP is investigating potential claims on behalf of shareholders of Vanda Pharmaceuticals, Inc. (“Vanda” or “the Company”) (NASDAQ: VNDA). If you are interested in discussing your rights as a Vanda shareholder, or have information relating to this investigation, please contact Finkelstein Thompson's Washington, DC offices at (877) 337-1050 or by email at email@example.com. Vanda is currently developing the drug Tasimelteon for treatment of non-24-hour disorder (“non-24”), a circadian rhythm disorder in which the patients’ internal “body clock” is misaligned, causing sleep irregularities. In late May 2013, the Company submitted a new drug approval application for Tasimelteon to the FDA. However, on June 19, 2013, thestreet.com published an article alleging several irregularities in the clinical trial process, including:
- 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.
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