Additional Dendreon Data Ahead of its Provenge FDA Review

I have received comments on Dendreon (DNDN-NASDAQ) for this week that are both positive and negative on how well its Sipuleucel-T (Provenge) is thought of ahead of the FDA panel review this week.  This is a very unique situation where there has not been as much coverage as in other cases.  Maybe the coverage will intensify as the week progresses.

I have been sent some data that seems very helpful in trying to make some determinations and some brief predictions.  You will have to make the real determination on your own, because the FDA is the FDA and that is an entirely different animal in making predictions.  But here is some of the data that may be of help:

There is a presentation from the Chemotherapy Foundation Symposium XXIV (November 8-11, 2006).  Scroll down halfway down the page and you can view Daniel P. Petrylak, M.D. presentation "Sipuleucel-T In Advanced Prostate Cancer."  It is roughly a 9 minute presentation but it gives some great data comparing Dendreon’s Sipuleucel-T who received DoceTaxel (Docetaxel was approved as Taxotere (R) in 2004 for Sanofi-Aventis(SNY)).

If you don’t want to watch an audio presentation with slides then you can read some of the basic data on it from the Nov 10 06 press release.  Here is Dendreon’s basic information link with some data as well.

There is a presentation made with slide show data for the FDA with a long transcript from earlier last year, but please be advised that its is a LONG TRANSCRIPT.  Here is a Download dendreon_provenge_powerpoint.ppton this.

This is no light matter, regardless of the investor community thought on this.  Breast cancer is a disease that has been a true burden to much of the female population.  Prostate cancer is the same for men, particularly with the old adage now prevalent: "If you are a man, you’ll probably get prostate cancer if you live long enough."  And, please, in no way is this meant in stressing prostate cancer over breast cancer.  Prostate cancer is something that has affected close family friends and the aftermath of it even after treatment and surgery goes above and beyond what men (and there wives and families) would consider a great quality of life. 

On March 1, Dendreon announced that the FDA Office of Cellular, Tissue and Gene Therapies Advisory Committee will review the Biologics License Application for PROVENGE(R) for the treatment of asymptomatic, metastatic, androgen-independent prostate cancer on March 29, 2007. The Center for Biologics Evaluation & Research has oversight of the Cellular, Tissue & Gene Therapy Advisory Committee.  So, what you can expect is that on this Thursday that trading of DNDN shares will probably be halted.  Be sure to watch the stock options in DNDN on Monday to Wednesday, because this one is getting more and more attention.

As a reminder, if things go very well for Dendreon, the company does have an active securities shelf filing that will allow them to raise up to $146.8 million.  That may be a wildcard in the scenario, but if the company is going to have a true blue winner on its hands in last line of defense against prostate cancer then they will probably have no trouble getting the market to absord the dilution.

It would not be appropriate for me to throw up a prediction without getting to evalue the actual panel and hearing their last thoughts right ahead of the meeting, and the chances of getting that is probably Zero Percent.  But there "may" some hope yet for such a critical problem, particularly since the late stage of cancer treatment here is meant not as a cure but as a life extender.  Investors on both sides have been making their bets.  I do have some more calls in that have not been returned and I am waiting on more data and opinions on this subject, so there is a shot that there will be more data posted by us ahead of the FDA meeting.  Also, we should get the NASDAQ Short Interest data for March early this week, but the FEB SHORT INTEREST was 20.3 million shares and that is a large number.

And I want to extend thanks to  Michael K for sending me some of the data here and some thoughts.  It was a lot of information and we do look into many things in depth like this when we can.  This is not purely user-generated content, but it does show that influential outside help from users and readers can be.  Thanks, Mike.

Jon C. Ogg
March 25, 2007

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