On September 10, 2008, Vanda met with the U.S. Food and Drug Administration (FDA) to discuss the not-approvable action letter that the FDA issued to Vanda on July 25, 2008 regarding iloperidone. The FDA asked Vanda to provide a complete response to the not-approvable letter highlighting arguments made during the meeting. Vanda expects to submit the complete response within the next few weeks. The timing or outcome of any FDA review of the response is uncertain at this time.
Vanda has suspended all commercial and development activities pending further review. Vanda has also reduced its cash burn and is reviewing a number of options to further reduce expenses and cash burn.
Operating Expenses. Third quarter 2008 R&D expenses, primarily consisting of salaries and related costs of R&D personnel, stock-based compensation, and the costs of consultants, materials and supplies associated with clinical trials and research initiatives, totaled $3.8 million, compared to $5.5 million in the second quarter of 2008 and $13.9 million in the third quarter of 2007. The decrease in R&D expenses in the third quarter of 2008 relative to the second quarter of 2008 is primarily attributable to lower costs in the Phase III tasimelteon chronic primary insomnia clinical trial for which Vanda reported top-line results in June of 2008. The decrease in R&D expenses in the third quarter of 2008 relative to the third quarter of 2007 is primarily attributable to lower clinical trial costs in the third quarter of 2008 compared to the costs from trials conducted in the third quarter of 2007 and the $5.0 million milestone charge recorded in the third quarter of 2007 resulting from the submission of the NDA for iloperidone.
-- General and administrative (G&A) expenses totaled $7.4 million in
the third quarter of 2008, compared to $8.5 million in the second quarter
of 2008 and $9.6 million in the third quarter of 2007. The decrease in
|SOURCE Vanda Pharmaceuticals Inc.|
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