A long and volatile era finally came to an end last week for Dendreon Corp as the US Food & Drug Administration granted approval for Provenge, the company's immunotherapeutic treatment for men with advanced prostate cancer.

The end of this era, however, marks the dawn of a new one. Doctors and patients have for years lobbied for a safe and effective alternative to radiation and chemotherapy treatments and the harsh side effects that come along with them. However, the efforts of these patients and Doctors were met with resistance, scepticism and even some alleged corruption by members of their own community who were more interested in their own personal financial investments than in a potential investment in the advancement of medicine.

The wait is over for those patients now, and for all who have long lobbied for this approval, and with Dendreon having spent much of the past year preparing for a commercial launch, Provenge should be on the market in the second half of this year.

According to previously released statements by Dendreon, estimated sales of Provenge could total between $60-$120 million during the second half of 2010, with sales of over $1 billion likely over the course of 2011. It's safe to assume that, based on those numbers, Dendreon expects a quick push to market.

This approval also comes as a welcome occurrence for investors of Dendreon, who bore the volatility of the past few years and can now say that they played a role in a company that very well may be writing the opening statement for a new chapter in the history of cancer treatment.

While still in the very early stages in a shift in the way that we treat cancer, it's likely that we could be on the verge of something big.

Along with the development of Provenge came the realization that the goal of immunotherapeutic cancer vaccine trials should be the overall survivability of the patient, and not necessarily tumor progression. It has also been suspected that these vaccines should be tested on patients with earlier stages of the disease, when the immune system is still intact before being battered by the cancer progression and treatments of chemo and radiation that follow.

The possibilities could be endless, and the Provenge approval may have opened the minds of many, including those at the FDA and of the two Doctors who allegedly fought against approval the first time because they were invested in a company creating a competing immunotherapeutic treatment that has since failed.

Let's take note to not get overly excited about an outright revolution in cancer treatment - many candidates have failed before Provenge, and Antigenics' claim to gaining the world's first cancer vaccine approval (for Oncophage in Russia) is questionable since that product has yet to make it to market.

However, Dendreon is an example in patience for the long term investor; there were plenty of opportunities to trade in and out through the volatility, but even those that held through it all posted huge gains. And from an investing standpoint, the gains realized by this one winner have more than made up for any lost investments in the cancer immunotherapy sector (let alone the whole portfolio).

That's why I like the speculative plays, it only takes one to hit to set you golden.

Even those that buy in now have the potential to post significant gains over the next couple of years, and in safer fashion since DNDN is no longer a speculative stock. The demand for Provenge could grow rapidly and approvals around the globe may be forthcoming.

So, while the CEO just sold a bunch of shares (well deserved winnings), there's no real reason to run away from the DNDN stock, although a dip or two could be in the works before the launch of Provenge in the US.

But in situations like this one, it's important not to be overcome so much by financial gain that you lose touch with the true meaning of what just happened - the approval of Provenge was a ground breaking event in the realm of cancer treatment; and the life of the late-stage prostate cancer patient just got a whole lot better.

Cancer vaccines could be the wave of the future.

It's good to get the sense that the good guys won sometimes, and with Provenge opening the door to cancer vaccine treatments, it's hard not to feel like the good guys won.

The adversity, resistance, greed and resentment was all there - but the patients will finally get what they've wanted - and needed.


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