Cyberonics VNS Therapy
This article was originally published in The Gray Sheet
Executive Summary
Panel-track, 87-volume PMA supplement for use of the vagus nerve stimulation system for adjunctive, drug treatment-resistant depression is submitted to FDA. The firm plans to present pivotal D-02 trial data in May 2004 at the American Psychiatric Association meeting and gain approval by October 2004 with expedited review (1"The Gray Sheet" July 28, 2003, p. 18). Separately, Cyberonics announces Nov. 5 a 12% jump in sales to $29.3 mil., and near tripling of earnings to $3.8 mil. in the fiscal second quarter (ended Oct. 24)...