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Cyberonics setback

This article was originally published in The Gray Sheet

Executive Summary

Amended PMA supplement for depression treatment with VNS vagus nerve stimulation will be submitted following receipt of a "deficiency letter" being prepared by FDA that raises safety, efficacy, clinical significance and trial design issues, the firm reports. The announcement follows a Feb. 4 meeting with the agency on the ongoing review of an October 2003 PMA supplement. After moving up its approval timetable in January, Cyberonics is now reverting to initial projections of a panel review this summer leading to approval by October (1"The Gray Sheet" Jan. 12, 2004, p. 8). Weak U.S. VNS epilepsy sales resulted in fiscal Q3 (ended Jan. 23) revenue of $28.4 mil., ahead 3% - but 10% lower than expectations. Earnings were off 62.5% to $1.6 mil. Cyberonics has reduced its sales force by 27 and plans a total force of under 175 to launch the depression indication later this year - down from estimates of 292 earlier this year...
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