FDA advisory committee meetings are notoriously unpredictable affairs, sometimes spinning out of control, spending hours exploring tangents of little bearing to the safety and efficacy of the product under consideration, or ignoring the criteria for safety and efficacy that must, by law, guide the agency's decisions.

While a stormy advisory committee meeting usually doesn't sink a strong product, it can lead to an expensive loss of public and investor confidence lasting weeks or months until FDA makes a final decision. In the most infamous cases, the FDA's decision to ratify a negative panel recommendation has forced companies to sacrifice their independence - even though their products ultimately were approved.