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Dendreon's Date With Destiny

Updated from March 8

Dendreon (DNDN) will take its prostate cancer drug Provenge in front of an FDA advisory panel on March 29. This is going to be a major stock-moving event, and for me, at least, the outcome is very much in the air.

I said as much in a column last week, but I also promised to dig deeper into the story. Having done so, here's a discussion of the issues surrounding Provenge's date with the FDA.

What is Provenge?

You might have heard Provenge referred to as a prostate cancer vaccine. That's an easy descriptor, but it's not entirely accurate because the drug isn't an inoculation and therefore won't prevent you from getting cancer.

What Provenge does is prime your immune system to recognize a certain protein expressed on prostate cancer cells. When your immune system encounters this protein they recognize it as foreign and it attacks. In this way, Provenge is really an "immunotherapy."

Neat stuff, has there ever been an immunotherapy approved by the FDA?

No, that's what makes Dendreon such an interesting story. Many other "cancer vaccine" companies have tried but failed. Dendreon is the first to seek FDA approval.

What's going to happen at the FDA advisory panel meeting on March 29? I've heard that this panel should be favorably inclined to like Provenge. Isn't this a good development for Dendreon?

Yes and no. The FDA's Cell, Tissue and Gene Therapy Advisory Committee that will review Provenge is a more hospitable environment for Dendreon than the agency's cancer division, known to be real data-driven sticklers. As analysts at LifeTech Research first pointed out in a Dendreon report, the CTGT folks are no pushovers, especially the woman who runs the division, Celia Witten -- she is tough. When she was a director in the FDA's medical device division, she led the effort to reject Cyberonics' (CYBX) neuro-stimulation device for depression, overturning the positive recommendation of an advisory committee panel.

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