Next pivotal event for DNDN

Tomorrow (April 28) at 12:20 pm Pacific time, Dendreon will present detailed results of Phase III clinical trials for Provenge, a prostate cancer immunotherapy.

Shares of DNDN tripled April 14, when CEO Mitchell Gold presented "unambiguous" top-line results that Provenge met its 22% primary endpoint survival benefit above the placebo control group.

Mike Huckman of CNBC is preparing several updates and interviews from Dr. Gold at the American Urological Association conference in Chicago. A "clear hit" as quoted by Dr. Gold two weeks ago, could cause shares of DNDN to soar even more. A disappointing result could cause shares to tank. Given his positive, upbeat announcement, while offering no metrics, I would be surprised if the survival benefit guideline was not surpassed by a wide margin, as that would invite shareholder lawsuits.

http://www.cnbc.com/id/30389525

Notice Huckman's comment on shares possibly being halted again. This could potentially be music to those long on the shares, as that occurred April 14 in pre-market trading, when the shorts got squeezed. Look for fireworks tomorrow.

FDA--Friend or Foe?

From the CaretoLive website. Activism is alive and well.

Provenge went before the FDA for approval over 2 years ago. A panel of experts was convened, who voted it 17-0 safe, and 13-4 substantial evidence of efficacy. Two “doctors”, namely Howard I Scher, and Maha Hussain, from the chemotherapy industry put on the panel by Richard Pazdur aka “the cancer czar”, both had severe conflicts of interest, and had to sign waivers although they conveniently left out many of their conflicts. They were both very vocal at the panel, that they needed more proof. Provenge has already been through over 10 years of Phase I, II and III testing.

The “doctors” lobbied the FDA to delay approval. Letters were leaked to the same inside non peer reviewed source that published the imclone erbitux non approval, sending Sam Waksal, CEO of Imclone, and Martha Stewart to jail. We believe that Richard Pazdur of the FDA was the “leaker”. Richard Pazdur of the Chemotherapy, Radiation side of the FDA, ran roughshod over the approval process, (passing notes to one of the conflicted doctors etc), even though Provenge is a biologic agent and did not reside in his division. Imclone’s Erbitux was subsequently approved for colon cancer, unfortunately not in time to help those who died waiting. A congressional hearing was called over Imclone.

We had several Congressmen call for a hearing over the Provenge debacle, but John Dingell of Michigan refused to hold it. His wife is tied to the cancer industry. Congressman John Dingell (Michigan) and Frank Pallone (New Jersey) decided against a Congressional hearing for all the wrong reasons. You can read their response to those calling for hearings. 2/13/08
micha001.pdf
Three Congressmen, Mike Michaud (D) of Maine, Dan Burton (R) of Indiana, and Tim Ryan (D) of Ohio called for a congressional hearing into the conflicts of interest and what went wrong at the FDA causing the delay of Provenge. (click this link) Read the Congressional Letter calling for a Hearing 12/13/07.

Besides, Congress is too busy holding hearings on steroid usage in baseball players, which nobody has died from. Who cares about 30,000 sick old American men. In reality, men are dying from prostate cancer in their 30’s and 40’s as well.

The really sick people are those running the FDA. They oversee a corrupt, dysfunctional bureacracy, with little care for the lives and health of the citizens of the United States. They are more concerned with power and lining their own pocketbooks.

Billions of dollars paid out to pharmaceutical companies, hospitals, stock holders, and Wall Street titans, will be lost, if the entrenched Oncology treatments are replaced by immunotherapies. This is an uphill battle, but one we need to fight, for all of our sakes.

Dendreon has immunotherapies for breast cancer, colon cancer, etc, on the back burner, due to the delay in Provenge approval, causing a depletion of their research and trial money. This is the way wall street plays the game and influences the FDA decisions. Delay and destroy. If not for Care To Live Provenge would have been long gone, possibly even being bought out by a larger company, whose goal would be to throw it in the trash heap, to ensure nothing interfere with their profits from the current toxic, debilitating treatments and the billions spent managing their horrible side effects.

The common protocols when you are diagnosed with prostate cancer is usually either removing your prostate gland, or some type of radiotherapy such as implanting radioactive seeds in your scrotum, which kill the cancer cells. Unfortunately they kill they healthy parts of your immune system too, and radiate your vital organs. You may also opt for watchful waiting now called active surveillance. Most men are encouraged to be treated. If your cancer progresses, they will give you hormone therapy, which is really female hormones, to try to supress your testosterone. All men who go on hormone therapy, will eventually fail, unless they go on to die from something else.

Provenge has show survival in 20% of the sickest men, those in late stage, who have already had either their prostate gland removed, or been radiated, and also had hormone therapy which is no longer working. These are men whose cancer has already metastacized to their bones and organs. Imagine what it might do, were it given to men earlier in their diagnosis. Once an immunotherapy is approved, it will be a paradigm shift in the way cancer is treated.

Michael Milken, runs the world’s largest prostate cancer charity in the world. He has been silent during this entire fiasco. The Provenge interim results of another Phase III trial were recently released, showing 20% survival. Not a word from him or his Prostate Cancer Foundation. It is apalling but not surprising. Milken, is a convicted felon who sent time in jail for stock manipulation, and has investments in Provenge competitors. His “faster cures” nonsense, rings hollow with us. He helped fund the Proquest Investment fund. He is busy shaking his can everywhere, asking for more funding to begin research 10 years away from approval, but has nothing to say about Provenge, which is ready, willing and able to be used RIGHT NOW! It is an abomination.

DNDN conference call

As I and other investors hoped for, Dendreon CEO Mitch Gold revealed "unambiguous" top-line results that Provenge met the pre-defined primary endpoint for increased survival benefit for late-stage prostate cancer victims in the IMPACT Phase III clinical trial. Shares jumped up over 200% in pre-market open trading. This was a victory for investors and all cancer victims and their families, as other treatments for breast, colorectal, and kidney cancer are also in Dendrean's pipeline. Their cancer immunotherapy platform is a game-changer, and a much better solution than traditional chemotherapy treatments, which carry toxic and adverse side effects.

This paves the way for a New Drug Application (NDA) by the end of 2009, and FDA approval in Q2 2010.

Shares of DNDN halted in after hours trading

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.