Cyberonics’ VNS Therapy Approvable As Last-Resort Depression Fix – Panel
This article was originally published in The Gray Sheet
Executive Summary
FDA's Neurological Devices Panel set aside its desire for an additional, randomized trial of Cyberonics' VNS Therapy depression indication at a June 15 meeting to review the device in Gaithersburg, Md
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SEC investigates Cyberonics
Stock options granted by the company on June 15, 2004 are under inquiry by the Securities & Exchange Commission, according to a June 9 8-K filing. The options were offered the same day FDA's Neurological Devices Panel voted in favor of approving Cyberonics' treatment-resistant-depression device, VNS Therapy, while shares were halted for external trading (1"The Gray Sheet" June 21, 2004, p. 3). The firm's issue leapt 78% to $34.81 from June 14, 2004 to June 16, 2004, the day after the panel decision. Cyberonics claims that the grants were approved by the board of directors without any management influence...
SEC investigates Cyberonics
Stock options granted by the company on June 15, 2004 are under inquiry by the Securities & Exchange Commission, according to a June 9 8-K filing. The options were offered the same day FDA's Neurological Devices Panel voted in favor of approving Cyberonics' treatment-resistant-depression device, VNS Therapy, while shares were halted for external trading (1"The Gray Sheet" June 21, 2004, p. 3). The firm's issue leapt 78% to $34.81 from June 14, 2004 to June 16, 2004, the day after the panel decision. Cyberonics claims that the grants were approved by the board of directors without any management influence...
Schultz’ Controversial Approval Of Cyberonics Device Has Little Precedent
CDRH Director Dan Schultz's decision to override device and drug center review staff to approve Cyberonics' VNS Therapy neurostimulation device for treatment-resistant depression has scant precedent in recent history. All the same, he appears to have followed established FDA procedures