Volatile Biotechs Are Always a Gamble

This is an awesome idea because, unlike conventional chemotherapy and radiation treatment, it's not a highly toxic compound that makes patients sick while they try to recover. Moreover, patients don't have a lot of choices. The most common treatment, a drug called Taxotere from Sanofi-Aventis(SNY Quote - Cramer on SNY - Stock Picks), doesn't work so well and causes miserable side effects such as nausea, hair loss and mouth sores.

The problem is that while Provenge has been found to prolong the lives of patients with advanced prostate cancer by four months, in one clinical study reviewed by a company-sponsored panel of scientists, it didn't meet its primary goal of slowing the spread of the disease. There are also questions about whether the trial was lengthy enough or included enough patients.

Though regulators are usually sympathetic to drugs that help people live a little longer, they don't usually approve therapies that don't actually meet their goals. Dendreon has told investors that a more comprehensive trial now under way, gauging the survival of 500 men with advanced prostate cancer, will not be concluded until 2010.

I'm not a scientist, but my own guess is that the FDA may balk at the investigative panel's findings in part because two clinical trials provided conflicting results that even a company consultant called "less than perfect." The first three members of the 17-person investigative panel last month voted against approval, but then the FDA changed its definition of effectiveness for the drug -- lowering the bar to help it pass.

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