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Food & Drug Law Weekly

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Cyberonics, Inc.



VNS-focused company raises Q2 earnings guidance



September 24th, 2004

Cyberonics, Inc., (CYBX) announced revised guidance for the second quarter ending October 29, 2004.

It also disclosed the regulatory options available to the company to obtain U.S. Food and Drug Administration (FDA) approval of its expedited review premarket application supplement (PMA-S) for vagus nerve stimulation (VNS) as an adjunctive long-term treatment for patients with chronic or recurrent treatment-resistant depression that have failed to respond to at least 4 adequate antidepressant treatments.

"We are raising our second-quarter earnings guidance from a net loss of $9 million, or $0.38 per share, to a net loss of $3.4 million, or $0.14 per...


Source: Food & Drug Law Weekly (2004-09-24)

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