Controversy-sparking drug developer Dendreon
After a $75 million convertible note offering in early June, Dendreon guided that its more than $140 million in cash and investments will be enough to last until it announces interim results of its ongoing phase 3 study of lead drug Provenge -- expected next year -- and still give it a cash cushion of around $75 million after that.
The interim survival results of the ongoing IMPACT study are still predicted for "the middle second half" of 2008, with final overall survival results expected in 2010.
As Business Week reported last month, several "patient advocacy" groups were suing the FDA and various officials over its decision to grant only an approvable letter for Provenge, despite a mostly positive advisory committee meeting in March.
These lawsuits are likely to be as successful as Encysive Pharmaceuticals'
When the briefing documents were released, issues that Dendreon never publicly mentioned before came to light. Examples include the FDA's contention that Dendreon was improperly counting the number of prostate cancer survivors at 36 months in the d9902a study, and that some Cox multivariate regression analyses (sensitivity tests evaluating the efficacy of Provenge with a variety of variables included or excluded) were open to potential manipulation by Dendreon.
In addition, the overall survival results on which Dendreon likes to hang the Provenge efficacy results were pulled from a post hoc analysis of the d9901 study, rather than even a secondary endpoint of the clinical trial. As the FDA reviewer states, "overall survival as an endpoint was NOT defined" in the study. Dendreon has announced this fact previously, but it's worth mentioning again.
One way or another, this pointless lawsuit won't have any meaningful effect on the ongoing phase 3 study for Provenge, nor will it reverse the FDA's approvable letter decision. The IMPACT study will be the sole determinant of Provenge's chances for regulatory approval, and it should be the sole basis for Fools' potential investment.
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