said it recently received a letter from the Senate Finance Committee stating that it is looking into the Food and Drug Administration's handling of the company's bid to get approval for its vagus nerve stimulation therapy for depression.
According to the company, the Senate committee is "examining the FDA's handling of Cyberonics' Panel Track PMA-Supplement for the VNS Therapy to address treatment-resistant depression (TRD) in adults." The letter continued that the "FDA issued an approvable letter to Cyberonics on February 2, 2005, despite the strong objections from FDA scientists involved in evaluating the safety and efficacy of VNS Therapy."
Cyberonics said the letter from the committee alleged no wrongdoing on the part of the company but did request that it provide certain information.
"Cyberonics and its advisors believe that SFC's 'examination' will produce no new information and that SFC's 'examination' will have no bearing on FDA's final TRD approval decision," Robert P. Cummins, Cyberonics chairman and CEO, said in a press release. "All of the 'strong objections' referred to in SFC's letter were fully considered by a specially chosen FDA Advisory Panel of depression experts that recommended approval in June 2004 and by FDA's Center for Devices and Radiological Health (CDRH) during its rigorous review of the Expedited Review PMA-S and PMA-S Amendment that resulted in the recent approvable decision."
Shares of Cyberonics were taking a hit in the premarket session, falling $5.46, or 14%, to $33.41.