Analyst who cast doubt on Provenge vaccine settles with SEC

Condition Price Change Volume. According to the International Securities Exchange ISE , 10, calls were bought to open on its exchange yesterday, compared to just puts purchased. Posted April 30, at 9: It needs a partnership with a big drug company. Jevtana will compete with Provenge for patients, although the demand backlog for Provenge while Dendreon ramps up its capacity, will make up for any sales losses from competition. He convinced Wall Street that his company, Seattle-based Dendreon, is not a bunch of dreamers but a crew that can deliver the next wonder drug for prostate cancer. Click here to register.

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Only English comments will be allowed. I have read Investing. Write your thoughts about Dendreon Corporation. Are you sure you want to delete this chart? Replace the attached chart with a new chart? Your ability to comment is currently suspended due to negative user reports. Your status will be reviewed by our moderators. Can I link my yahoo finance to my ameritrade broker account?

Would you ever consider a cat's litter box a 'safe' place to hide valuables? Can I buy and just hold stocks without additional cost? How to perform futures trading? Is there a service that can assist me in challenging my stock brokerage informing me that I must leave them? I want to invest into stocks.

What is the easiest way to invest at 18? And could someone explain how the stock market works.? Amzn stock has a PE ratio of and pays NO dividend. Why would anyone buy this? I revealed, in a footnote at the bottom of my Letter to the Editor, that I was a Dendreon shareholder. What difference would it make if I owned , 10,, or , shares?

Even if you knew the number of shares I owned, how would you know what I paid for the stock? All of the above, at one time or another? Did I sell or purchase options? Even more to the point, as a matter of practicality, just the thought anything I write or do regarding Dendreon can move the price of this stock is fantasy.

Get a grip on reality! How fair is it when you accused of others having some detailed conflicts of interest and you avoided disclosing yours? May you have a good luck! For those who want to use the product, you certainly have your choice but the risk of not prolonging but shortening your life is highly present with the current uderstandings of the data. In contrast, a lots of products that have shown antitumor activity failed to translate into clinical benefits.

Use of Provenge before Zytiga in the prechemo setting is purely an assumption, proposed by those who has been misled or ill-willed either academically or finacially.

For a sham prodcut, does sequencing matter anymore? Hope Zytiga data tell more in coming months. Seals was fortunate indeed that he was able to obtain the data needed to file a formal Appeal with Washington State authorities in the matter of Kaiser Permanente initially rejecting his application for Provenge based on their invoking the Huber JNCI paper.

He is now undergoing his first Provenge infusion. Current thinking,however, is that prescribing Zytiga first will delay medication with Provenge. Detox can take up to 60 days. Giving Zytiga first off-label and then, having to wait for the patient to detox, could result in the disease progressing to the point where the patient no longer is eligible for Provenge.

This issue was addressed in the Journal of Clinical Oncology, which made the following recommendation:. For now, given the broader window of applicability of abiraterone and the longer time required to develop an immune response with sipuleucel-T, if both agents are to be used, it seems reasonable to administer sipuleucel-T first with Abiraterone after additional disease progression. Biomarkers to help define the optimal use of immunotherapy are needed.

Dendreon and JNJ currently are running sequencing trials to determine whether or not the two treatments can be given concurrently or a detox period must be imposted if Zytiga is given first. This is why studies related to sequencing are so important. The analysis in the ASCO abstract was based on a regression analysis, first assuming some functional model, i. RPSFT preserves the original randomization to avoid biases and do the correction based on some assumption about the goodness of the cross-over protocol.

In this case, Dendreon assumed that the cross-over protocol had a good an effect as the treatment protocol. Nonetheless, one could still argue about whether RPSFT is an appropriate model for a post-hoc analysis. Is it right for anyone to call you dishonest for not revealing all your investments so that they can tell which one may be competing with Dendreon?

Please stop the nonsense of accusing people of some sort of ulterior motives and just focus on the facts. So the slight improvement of the MST in the paper to The point in the above is that these median numbers are not exactly cast in concrete.

So when you use them, you have to be careful to see the limit of validity in your usage or computations. Making an absolute comparison between two medians for better or worse without considering their confidence intervals ranges from being naive to being nonsensical.

Btw, this was one of the things wrong with Ms. Now back to the Provenge and Atrasentan data. The MST of the control arm was This CI overlaps with that of the control arm of the Atrasentan trial with a slight shift to the right.

As to any imbalances in prognostic factors that may influence such numbers, nobody here really knows. And, btw, this is another thing wrong with Ms. What imbalances lurked in those subgroups and how did she account for them? I already have stated that I am a shareholder.

Beyond that, I have no obligation to reveal personal information to you, financial or otherwise. It is absolutely fascinating to follow this discussion and I thank you all for posting.

I am a front line FD in Canada whose involvement it the treatment of prostate cancer patients consists of indentifying those who might suffer from one, referring them to urologists , following them with oncologists while they receive hormonal treatment and taking them over after chemo fails to comfort them in their final days… I am making patients very aware of the Provenge while they are still responding to hormonal suppression.

There are some of them who are willing to pay for Provenge treatment in US. Provenge is not available in Canada but Zytiga already is! I guess one cannot underestimate the power of BP! Be honest to the public, disclose how many shares you have in DNDN then continue your discussion.

I had and have 0 share, but i have seen prca for years. The IMPACT had about 80 percent of patients with asymptomatic diseae and about 20 percent with minimally asymptomatic disease, all had NO visceral involvement. The median survival was More importantly, the atrasentan trial was stopped 14 months before taxotere was marketed in The placebo arm results contained patients who received frovenge.

Of course the frovenge patients showed a survival almost if not as good as the provenge treated patients. Thats because the provenge patients included patients as sick as the placebo group who did not receive frovenge.

There is a subgroup of patients in any trial who do poorly. The frovenge patients had those weeded out whereas the provenge patients did not. So its not a surprise that frovenge patients did well because they were the sunsgroup that did not rapidly progress. Another interesting trial would be to compare frovenge with provenge.

I suspect frovenge would do worse because the rapidly progressing group would be in both arms and not just in the provenge grup as in the impact trial. The only way to test frovenge versus provenge would be to do a randomized trial. That, like provenge versus placebo in this population will never happen. So there will always be unanswered questions as is the case in most therapies. However, to assume provenge has a median survival benefit of 7. The frovenge group were a faverable subset. First, you asked the wrong question.

Consider a trial with similar patients, the phase-3 trial for Atrasentan on minimal pain metastatic prostate cancer. The median survival time for those patients was about Where is the evidence that Immunodepletion harmed them?

And, how did the Provenge patients perform? So, Provenge did act early to keep a higher number of treated patients living past one year comparing to if they were not treated. The Provenge MST was 4. Btw, a post-hoc analysis correcting for the cross-over effect that Dendreon recently presented at ASCO showed that the median difference between Provenge and pure placebos could be as high as 7.

That is in line with the above. Frovenge contained more than damaged monocytes. It contained frozen celss incubated with the casette. The cassette contains gmcsf a potent stimulant. APCF frovenge A vaccine made from immune system cells taken from a patient with prostate cancer and frozen for future use. The cells are treated in the laboratory with a growth factor attached to a protein called prostatic-acid phosphatase PAP , which is found on prostate cancer cells.

Dendreon is going to run a trial with a true placebo. I covered this in an earlier article on Seeking Alpha but neglected to mention it above. Here is what I said earlier:. In particular, he stressed that the placebo arm in this trial would be a true placebo … that is, one that did not include frozen Provenge, or Frovenge, as it is known.

As such, he said, the company anticipated a much higher overall survival, or OS, advantage than what had been observed in the pivotal Provenge trials.

I think we all want to see the results from this trial, all be their release several years into the future. You have raised a very important point in your comment regarding the Phase 3 trial design for Provenge. At the very least their paper clearly shows that the Dendreon data are tainted by a poorly constructed placebo arm.

Better might have been to not remove cells in placebo patients, but to run a sham apheresis and infuse a bag of saline no cells. However, this approach would have prevented possible crossover of placebo patients to an active arm later on which utilized the frozen cells. It is an unfortunate fact, perhaps, that the protocol for the Phase 3 trail, which was developed in close coordination with the FDA the agency, or course, had final approval , specifically included a provision to allow patients to cross over and take a frozen form of Provenge Frovenge.

This was done to encourage patients to enroll in the trial. It gave them additional hope that they would have a chance to receive a form of the experimental treatment and derive whatever benefit from it that was possible.

As was seen in two post-approval analyses that I discussed recently on Seeking Alpha http: In fact, the use of Frovenge was a case where the trial design almost failed the treatment. Put another way, Frovenge was so good that patients crossing over achieved a median life-extension benefit that was almost as good as that provided by Provenge itself.

One of the major problems the FDA and the pharma industry must come to grips with today is how to handle the crossover problem in trials such as the one conducted for Provenge. The problem that JNJ now faces is this.

While their Phase 3 trial was stat sig on ONE of two primary endpoints—progression free survival PFS —the study failed to achieve stat sig on the second primary endpoint: Now, with patients crossing over from the placebo arm and taking Zytiga, the chances of JNJ being able to demonstrate stat sig for OS are being reduced by the day, jeopardizing approval of the drug in the pre-chemo indication.

Zytiga already is approved for post-chemo applications. You obviously have no clinical experience in treating prostate cancer. There are 3o,ooo deaths per year frm prostate cancer. To say that a high death rate in the first year is unacceptable is ridiculous. In the dndn trials,the patients had advanced hormone refractory disease with established mets.

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At Yahoo Finance, you get free stock quotes, up-to-date news, portfolio management resources, international market data, social interaction and mortgage rates that help you manage your financial life. DNDN: Get the latest Dendreon stock price and detailed information including DNDN news, historical charts and realtime prices. Dendreon failed to live up to expectations for its new prostate cancer drug, and now it is facing some brutal consequences. The Seattle-based biotech company (NASDAQ: DNDN) saw its stock plummet.