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2006P-0370
SUP 1
Volume 1
Cover Letter
Tab 6 - Kelly S. Profits elusive for Cypberonics, shares plunge.
Reuters, August 1, 2006. Published
Material
Tab 7 - Stine N, Lurie P, Wolfe S. Letter to FDA urging that the
Vagus Nerve Stimulator not be approved for treatment of depression
(HRG Publication #1741). Available at http://www.citizen.org/publications/release.cfm?ID=7385
Published
Material
Tab
10 - Committee on Finance, United States Senate. Review of the
FDA's approval process for the vagus nerve stimulation therapy system
for treatment-resistant depression. February 2006. Available at:
http://finance.senate.gov/press/Gpress/02_2006%20report.pdf
Tab
13 - Food and Drug Administration (2004): Final Statistical
SUmmary Review for PMA P970003/S50 (Original and Various Amendments),
Vagus Nerve Stimulator (VNS) Therapy System for Depression, Cyberonics,
Inc. Accessed 9/4/06 at http://www.fda.gov/ohrms/dockets/ac/04/briefing/4047b1_00_a_FDA%20Statistical%20Review%20Memo.pdf
Published
Material
Tab 14 - Nemeroff CB, Mayberg HS, Krahl SE, et al. VNS therapy
in treatment-resistant depression; clinical evidence and putative
neurobiological mechanism. Neuropsychopharmacology 2006; 31: 1345-55.
Published
Material
Tab 15 - Armstrong D. Medical reviews face criticism over lapses.
Wall Street Journal, July 19, 2006, p. B1. Published
Material
Tab 16 - Armstrong D. Medical journal editor to quit in wake of
disclosure oversight. Wall Street Journal, August 25, 2006. Published
Material
Tab 17 - Corcoran CD, Thomas P, Phillips J, O'Keane V. Vagus nerve
stimulation in chronic treatment resistant depression. British Journal
of Psychiatry 2006; 189: 282-3. Published
Material
Tab 23 - Mark D. Vagus nerve stimulation for treatment-resistant
depression. Technology Evaluation Center, Vol. 20, No. 8, August
2005. Available at http://www.bcbs.com/tec/vol20/20_08.html. Published
Material
Tab 24 - Clarke T. Blue Cross to again reject Cyberonics device.
Reuters, August 8, 2006. Published
Material
Tab 25 - Anon. Blue Cross rejection sends Cyberonics stock tumbling.
Houston Business Journal, August 8, 2006. Published
Material
Tab 26 - Cyberonics. Cyberonics revises guidance for FY07 and confirms
receipt of NASDAQ staff determination letter. Cyberonics press release,
August 1, 2006. Published
Material
Tab 28
- Cyberonics. Form 8-K. Filed with U.S. Securities and Exchange
Commission July 31, 2006.
Tab 29 - LurieP, Stine N, WolfeSM. Letter to FDA requesting the
immediate halt of Cyberonics ads for vagus nerve stimulation devices.
May 18, 2006. Available at: http://www.citizen.org/publications/release.cfm?ID=7434&secID=1163&catID=126
Published
Material
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October 12, 2006
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