Before the bell this morning, the ever-popular Dendreon put out a press release ahead of its presentation later today at the Bank of America Healthcare Conference in Las Vegas. You can listen to the presentation via Webcast at 1 p.m. ET. The company says that the Food and Drug Administration has confirmed that it will "accept either a positive interim or final analysis of survival" from the ongoing, larger clinical trial on Dendreon's highly controversial prostate cancer treatment Provenge.
Analysts expect the interim data to be available around the middle of next year. So, that means that if the FDA accepts the interim data that the drug potentially could be approved and on the market in the second half of next year. On the other hand, the release says the FDA will accept "interim or (my emphasis) final analysis". If the agency waits for the final data, that means the drug might not get a decision until 2009 or 2010.
Nonetheless, DNDN is rallying in early trading today, once again on very heavy volume. Investors just can't seem to get enough of this roller-coaster biotech ride. Dendreon CEO, Dr. Mitchell Gold, is quoted in the release as saying, "We are committed to making PROVENGE available as rapidly as possible to help the many men with late-stage prostate cancer who currently have few appealing treatment options."
A grassroots campaign by patient advocacy groups to get the drug approved sooner rather than later is underway. They plan to meet soon with FDA Commissioner Dr. Andrew Von Eschenbach, and to visit lawmakers on Capitol Hill early next week. But at this point, it sounds as if the regulatory wheels are back in motion.
Now, the hot debate will resume over whether the current Provenge study will indeed show what's called a significant survival benefit. In the earlier, smaller studies Dendreon reported that some patients lived about four-and-a-half months longer, without the undesirable side effects of current prostate cancer drugs or safety problems. But critics maintain the study was too small and that survival wasn't the main goal of the study so, therefore, by clinical trial standards you can't read much into the results.
The ongoing Provenge study is enrolling several hundred patients. The company says it expects to complete enrollment this year and to have the interim survival results in 2008.
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