Dendreon, a Seattle-based biotech specializing in cancer immunotheraphy, will be announcing top-line results of a phase III clinical trial for Provenge tomorrow. The pivotal metric is whether patients with prostate cancer will have a 22% survival benefit from Provenge vs. the place control group.
An advisory panel gave a recommendation to the FDA of approval in 2007 based on a positive safety profile and promising interim survival benefits. But in a controversial move (especially for life-threatening oncology treatments), the FDA did not approve Provenge, seeking more results for this IMPACT clinical trial.
The results will be announced tomorrow in a conference call at 6 am PT. If Provenge meets its 22% survival benefit benchmark, the share price for DNDN will explode. If they miss their target, the share price could collapse to almost zero. Such is the life of a biotech microcap company.
If IMPACT proves effective, it could open the doors for immunotheraphy of other cancers, and could be a game-changer for oncological treatment. For investors and patients, let's hope this one is a winner.
Monday, April 13, 2009
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