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DENDREON (DNDN): Lessons from History

Apr. 30, 2010 10:32 AM ETDNDN
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Are we lovers of redundancy? No. We are lovers of fairness and the lack of it cannot be visualized unless what goes on wrong gets caught and documented by history. Dendreon’s (DNDN) history, as written in the Prohost news on Prohost website, illustrates how unfair has been Wall Street evaluation to clinical-stage firms during the past decade and how tremendous were the opportunities investors have let escape from hand by relying on misleading evaluations. If you Search Dendreon on Prohost website and start to read the articles from bottom up, you will read:

March 14, 2006

DENDREON (DNDN): The stock had a negative performance because analysts expected a fourth-quarter loss of 34 cents, which the firm exceeded by a couple of pennies! The share lost $1.36 when analysts expected $1.31 loss per share! The stock was sold because revenues were less than analysts’ expectations. (How wise is it to buy and sell development-stage biotechs that have no products on the market based on revenues?) Dendreon’s value, stock price and its whole future depends on its investigational drugs, especially Provenge. All the other factors mean nothing.

March 20, 2007

We are at the end of the road with Dendreon’s (DNDN) prostate cancer product Provenge. Before the end of this month, the FDA advisory panel will discuss and debate the drug and vote on whether it recommends approval or not.

We are at the end of the road with Dendreon’s (DNDN) prostate cancer product Provenge. Before the end of this month, the FDA advisory panel will discuss and debate the drug and vote on whether it recommends approval of Provenge. The firm’s actions taken in the past year make us believe that it is highly optimistic about the drug and expects …..

Regardless. The firm’s mood and of its shareholders will depend on the FDA Committee this month, but its fate, will lie in the hands of the FDA, which will issue its verdict on May 15. Nobody will be interested in knowing whether the $120 million in cash and investments the firm still has is sufficient to carry it through the year or through two years. An approval will turn this sum of money into extra-money. If Provenge will be approved, Dendreon will no more be called development stage that spends without revenues. The published results that we saw look promising. Yet, after March 28, the stock price will depend on the Committee’s decision and two months later, it will depend on the FDA's decision, which will be the maker, or the breaker of this great firm. We wish the best for the prostate cancer patients and for Dendreon and its shareholders.

You have then to read Prohost Letter to learn how furious we were against the decision made against approving the drug, especially that the FDA appointed committee voted almost unanimously in favor of approval. In the Prohost issues, we openly pinpointed to the corruption of specialists whose actions were flagrantly misleading investors and affecting the FDA decision. Those people looked determined to bring the stock down at whatever cost. (The issues can be viewed by subscribers on the website)

March 25, 2009

Here we go again. …… we begin to hear noises around the drug’s approvability. This time, it is not about whether the vaccine prolongs life or not, but about technicality!

Now it is Dendreon that has imperiled the its therapeutic vaccine study. How? By the firm issuing a press release last October, demonstrating that Provenge cuts patients' death rates by 20% compared to placebo. The release, the writer said, contained statistical details that made good results seem likely when final results are released in April.

So, according to the negative article introduction, one can understand that even if the drug demonstrates prolonging lives of condemned patients, the FDA may choose to deprive other condemned patients from having the effective vaccine. Why? Because of technicality?!

To make their point, the article presented four statisticians stating what can be summed up as follows: “Dendreon may have compromised the integrity of the trial by putting out the release”. We also read, “It was unorthodox for Dendreon to even know such a detailed result, much less to publicize it.” The statisticians have also stressed the reasons why the FDA should reject the vaccine. Please read what they said, “The company, patients or doctors might have changed what they were doing once they knew how the study was going. If the final outcome is only marginally statistically significant, it might be tossed, putting Dendreon and its drug back at square one.” Hello there. Are you paying attention to the reason why the FDA should reject the vaccine?

You know what? We understand the meaning of malignant insinuations and the direct and indirect messages the insinuators send and why they do so. Such negative hinting has become part of our natural environment. However, we do not find it smart trying to insinuate that publishing the results of Dendreon's study, which deals with survival, would enable the firm and the physicians, let alone the patients, to change the outcome of the study at the last minute.

As for the suggestion that the patients are among the conspirators, the only possibility for them to conspire is that the dead among them would pretend they are still living. And so forth.

Are we witnessing the same happening now against development-stage biotech firms? Of course we are and we write about it all the time. Recently, articles disguised in scientific robes have been surfacing, confirming that no therapeutic vaccines will be approved in this decade, if at all. Recently, we have seen Gilead Sciences’ (GILD) cremated because it generated product sales, revenues and income more than ever before, and we witnessed development-stage biotech stocks being subjected to sell-offs because of missing analysts expectations by a couple of cents.

Anyway. All we can say now is congratulate Dendreon and its shareholders. They struggled together for long and, now, they triumphed together. They deserve to celebrate. More important than all is that late-stage condemned prostate cancer patients received a great gift.

A new hope.

Longer On Dendreon



Disclosure: LONG DNDN

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