Never invest in a company with a ceo nicknamed "Skip"? :-)
Very dumb PR, but still a fun read:
Press Release Source: Cyberonics, Inc.
FDA Ignores Panel Recommendation and Determines Cyberonics' Expedited Review Depression PMA-Supplement Not Approvable
Thursday August 12, 7:02 am ET
4.4 Million Americans with treatment-resistant depression left with no long-term treatment option
HOUSTON, Aug. 12 /PRNewswire-FirstCall/ -- Cyberonics, Inc. (Nasdaq: CYBX - News) today announced that late yesterday it was notified by FDA in writing that "notwithstanding their (the Neurological Devices Panel's) recommendation, we regret to inform you that (your) PMA-Supplement, absent additional information, must be considered not approvable." FDA's stated reasons included worsening depression, potential biases stemming from a non-randomized control and an inability to distinguish one-year VNS effects from placebo and concomitant treatment effects.
"We are shocked and bewildered by FDA's decision to ignore its expert Advisory Panel's recommendation," commented Robert P. ("Skip") Cummins, Cyberonics' Chairman of the Board and Chief Executive Officer. "FDA's Center for Neurological and Restorative Devices had no prior depression experience before the VNS submission and as a result, FDA deputized four of the seven voting members of its expert Advisory Panel. All four of these deputized members were psychiatrists, including three who also serve on the antidepressant drug Advisory Panel. All of the reasons cited in yesterday's not-approvable letter were addressed at the Panel meeting on June 15 prior to the Panel's vote recommending approval. FDA has now chosen inexplicably to ignore not only the recommendation of its panel of experts, but also the strong recommendations of numerous psychiatric thought leaders and the compelling testimony and needs of people with treatment-resistant depression who today have no long-term treatment for their lifelong and life-threatening illness."
"Depression is the leading cause of disability for women in the U.S., and every month an estimated 2,500 Americans with treatment-resistant depression commit suicide," continued Mr. Cummins. "The VNS studies targeted patients with extreme treatment-resistant depression that are excluded from other antidepressant studies, including studies of electro-convulsive therapy (ECT). Despite the extreme treatment resistance of the VNS patients, after one year of treatment, one out of six were depression free and 56% had realized a meaningful benefit. Most importantly, approximately 70% of the VNS responders sustained their response out to two years. By comparison, an active control group of similarly resistant patients treated for one year with currently available treatments (no VNS) predictably showed minimal response and no sustained response. Once again, FDA's specially chosen Advisory Panel of experts considered this one-year data to be compelling and sufficient to recommend approval."
"This is the first Expedited Review PMA-Supplement in history with a favorable Panel recommendation that has been determined by FDA to be not approvable," concluded Mr. Cummins. "In its letter, FDA seems to be rationalizing its unprecedented decision based on FDA's seemingly arbitrary preference for a randomized controlled study that is neither required by the regulations nor the norm in the majority of device approval precedents reported by FDA in a recent CDRH Staff College Report. Apparently, FDA believes that the absence of a randomized control is adequate justification to leave 4.4 million Americans at significant suicide risk without a treatment option. FDA's expert Advisory Panel, people living with treatment-resistant depression, psychiatric thought leaders, payers and all of us at Cyberonics strongly disagree."
"We are in the process of arranging a meeting with senior FDA management to discuss their letter," commented David S. Wise, Cyberonics' Vice President and General Counsel. "We are actively considering all regulatory and legal options, including those successfully employed by other device companies to reverse inexplicable decisions and obtain PMA approvals."
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