Today is the first day that a revolutionary new treatment for cancer becomes available to all patients who need it. It is amazing that we are all here to witness it. I have a few thoughts and thanks that I'd like to share.

 

First, it was great to see both Jimmy and Toos posting today. If Walldiver comes to say hi, that would complete it for me. These three were among the people whose posts I always looked for to learn about Provenge and Dendreon in my earlier days of investing in DNDN back in 2003. Nowaday, some people actually believe I am trained in statistics and even the science behind Provenge :). Far from that, words like Kaplan-Meier, log-rank, p-value, antigen, etc., were just another foreign language for me to learn in those early days. Wall was the first person who had the patience to explain the significance of the TTP Kaplan-Meier curves to me back then. And, a subscription to David Miller's BSR taught me much of how Provenge works. After that, much of the learning was on the fly as needed and often with help from various discussion on this board with people such as Rufustoehee, Clarksterh, Hirogen and many many others. To everyone, I am grateful.

 

It has been humbling to see the passion and dedication of Provenge advocates headed by such fine people as Yarbonero, MrSerious, AMMAS and KDDublin. These are the heroes who created the public hyper-awareness of Provenge so that what happened in 2007 would not have any chance of happening again. The FDA has instituted many changes in the Advisory Committee process likely due to that publicity. This same publicity will play a role to make Provenge a success in the days ahead. To them, I am in awe.

 

Now back to Dendreon itself. The company is now on a well-defined and well-paved path toward becoming a major biotech, perhaps, in time, even "the major biotech" for treatments of cancer. In the days ahead there will be minor carpings about this and that from different quarters on the Provenge data or its marketing or whatever. The bottom line is this: (1) Provenge has been approved as the frontline treatment for a very broad class of patients in the HRPC space, (2) it is far better than the only other approved drug for HRPC, Taxotere, both in efficacy and safety, and (3) it is being managed by an extraordinary management team with vision and dedication to make it a success.

 

Provenge for HRPC alone will be a multi-billion dollars enterprise a few years down the line. But that is just the beginning. Dendreon is advancing Provenge toward earlier stages of the disease including even as an adjuvant to primary treatment someday (the NeoACT trial).  Another phase-3 trial, P-11, is still running to test Provenge in the androgen-dependent stage of prostate cancer, ie, the stage just before HRPC. The ADPC market is multiple times larger than the HRPC market! And, that is a possible place where for many patients, a Provenge treatment might actually be seen as a cure of cancer for them.

 

Early data from P-11 already showed statistical significance for reduction of PSA Doubling Time. The next clinical endpoint being tracked for is Time to Metastasis. There are a number of research works indicating that PSADT is a strong predictor of metastasis. This means that the likelihood of success for TTM is very high. Indeed, even with only 16% patients showing metastasis in 2006, the hazard ratio was already 0.73. This will improve with time. I believe that TTM for P-11 will come late 2011 or early 2012 and the hazard ratio will be much better than 0.73 then. This would situate Provenge in a good position to run another trial for label extension. If Circulating Tumor Cells turns out to be a good surrogate endpoint, that will speed up the process significantly.

 

The approval of Provenge opens up the door for various combination approaches with other agents. The company will no doubt pursue a number of them. But again, Provenge is just the first in a long line of possible cancer treatments that can be developed from the Antigen Delivery Cassette Platform. For example, next in line for a phase2/3 trial is Neuvenge for bladder cancer. Neuvenge was already tested in two phase-1 trials for Her2-positive patients with breast and ovarian cancers yielding good data. Patients were seen with stable disease even after failure with Herceptin. Many other treatments will come from the platform.

 

So, IMVHO, Dendreon is a company that is destined to be a major player if not the leader in the fight against cancers. I am glad that many of us here had the fortitude to ride through the ups and downs over the years with the company. The years ahead may or may not be less turbulent but for me at least the experience should be far more pleasant no matter what.

 

Lastly, I'd like to make a couple of recommendations to fellow investors. As Toos said, if you invest in biotech and especially if you keep an interest in DNDN, there is no better source of information that you can pay for than a subscription to David Miller's BiotechStockResearch (www.biotechstockresearch.com). In addition, this board has been, by far, the best place anywhere to get timely information about Dendreon. Much of the thanks go to Blue and his team to keep the board from getting Yahooey with the occasional rancor from certain posters. To the extent possible, anyone who has gotten benefit from information on this board should sign up to support Blue in his good work.