Cyberonics Mulls FDA Appeal

Cyberonics rises and falls with FDA announcements... As quickly as Cyberonics rose in June on news that an FDA advisory panel had recommended approval of its implantable device for treating depression, it crashed on August 12 on news that despite this recommendation, the FDA had rejected the device. At the time the Company held a lengthy and clearly angry conference call. Today’s call was much more subdued and much shorter, announcing that it would first consider an informal appeal to the FDA but it will also look at the possibility of a formal appeal or conducting a new study. It also described the potential financial impact of the rejection on the company’s future financials.

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