They weren't the kind of monster moves we've seen in the past from Dendreon
On the positive side, news out of AstraZeneca
Zibotentan is still in two other phase 3 trials. One is testing the drug in patients before the tumor has metastasized -- spread outside its primary location -- which shouldn't affect Provenge sales much since it's only approved for metastatic prostate cancer. The second trial is testing zibotentan in combination with sanofi-aventis'
The bad news came later in the day after the Centers for Medicare & Medicaid Services (CMS) posted the questions for its Nov. 17 meeting to determine a national payment system for Provenge. The agency is questioning both its off-label and its on-label use.
Dendreon has secured reimbursement from insurers -- Aetna
The evidence clearly points in the direction in Provenge working; that's why the FDA approved it, and the label is based on the clinical trials run by Dendreon. Unfortunately, the questions aren't yes-or-no answers. Instead the panel of experts are expected to rate their confidence on a scale of one to five. That leaves open the possibility of ambiguity, investors' worst enemy.
At the end of the day, after the ups and downs, Dendreon closed down just 1.3%. That's probably about right. As with its deal with GlaxoSmithKline
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