All the erratic trading occurring in the stock market has proven to be quite difficult and frustrating for investors. Even in the midst of this topsy-turvy market, there are some interesting stories to be heard in the biotechs. Take for instance, Dendreon/NASDAQ: DNDN.Interest in Dendreon has been spurred once again since three members of Congress have asked the House Energy and Commerce Committee to hold a hearing about alleged conflicts of interest by two of the outspoken doctors who sat on the FDA panel that reviewed the prostate cancer drug and who voted against recommending approval. The news has caused shares of Dendreon to spike and since then it shares has settled down.
Currently, investors await the Phase III IMPACT trial data. The FDA review of the BLA for Provenge has lead to the FDA’s request for a confirmatory trial to substantiate survival claims. In October 2007, Dendreon completed enrollment (over 500 patients) of the pivotal Phase III IMPACT trial on schedule. We will remind investors, that management expects to conduct an interim overall survival analysis of the trial in the second half of 2008 after a predetermined number of death events have occurred. The primary end point of the IMPACT trial is overall survival in men with metastatic hormone-refractory prostate cancer receiving Provenge versus placebo. Time to disease progression is a secondary endpoint. The final analysis is still expected in 2010.
Back in 2007, Provenge was issued an approvable letter by the FDA and the agency indicated that either statistically significant interim or final overall survival results from the IMPACT trial would be sufficient to support the BLA of Provenge. Dendreon’s share price could escalate as investors place their bets on the outcome of the FDA’s decision. There are plenty of regulatory arguments for and against Provenge, but we think Dendreon is worth taking a chance.
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