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The Richest Woman in the World: How Gina Rinehart Earns her BillionsDendreon (NASDAQ: DNDN) is a classic example of how a company fares as they struggle through the arcane and sometimes bewildering process of gaining FDA approval of a new treatment protocol.
A little more than a year and a half ago, the Seattle-based company was anxiously awaiting FDA approval of its new drug treatment protocol for prostate cancer.
The company's new drug, Provenge, had completed a trial that found that the treatment extended the lives of men suffering from prostate cancer an average of 4.5 months over those who did not receive the treatment. The company felt it had adequately demonstrated the efficacy of the treatment and deserved FDA approval.
In an unexpected but somewhat typical move, the FDA chose not to approve the drug for distribution at that time. It opted to delay approval until completion of another study under way with 500 subjects. This came in spite of a finding by an FDA panel that the drug was "safe and substantially effective."
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