Banc of America has noted that yesterday’s ‘positive data’ is actually not new and that the interim data will not be available until the second half of 2008.  Mitchell Gold, MD/PhD/CEO of Dendreon, detailed the FDA’s decision to accept either a positive interim or final analysis of the IMPACT study.  He also updated the company’s financial guidance at the BofA Healthcare Conference.

Dendreon has already discussed the S.P.A. of the IMPACT study during the earnings conference call for the first quarter of 2007. The exact death event number for interim analysis and the p-value hurdle were again not disclosed, but management hinted that the interim analysis may be triggered when death events exceed at least 164, approximately the combined death events of the 9901 and the 9902A studies.

Dendreon maintains that it believes the study can show a statistically meaningful interim analysis, although this should be expected and there was not really any detail.  A further potential flag is thatthe company has said the interim goals will be hard to reach.

To sink a further axe into the stock, Banc of America has reiterated its Sell Rating and warns that this could go to $4.00 over the coming year and warns that it faces financial issues on the financing of its current trials.   Perhaps the CEO could call the coordinator for that Banc of America conference and say "Thanks for having us, and thanks for slamming us."

You can imagine what the provengenow.org will be saying about this.  Also, I have been sent several ‘factual’ emails pointing to how there are significant and blatant conflicts of interest with doctors on FDA panels that have been instrumental in the current blockage of Provenge. That is still an outstanding issue, and the actual resolution or end game is still a long ways off.

Jon C. Ogg
June 1, 2007

Jon Ogg can be reached at [email protected]; he does not own securities in the companies he covers.

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