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  • Dendreon Gains Will Be Short-Lived [View article]
    I can't believe you meant that, Dana. If you did, your loss of humanity is staggering.

    Ted
    Feb 7 09:28 AM | Likes Like |Link to Comment
  • Dendreon Gains Will Be Short-Lived [View article]
    We can and will have the debate, Dana.

    But again, please get your facts straight.

    If you receive Provenge, you are NOT assured of a 4-month life extension benefit. You may receive no life extension benefit. Then again, you may receive a 7 to 8 year life extension benefit. Have you ever discussed this matter with Dendreon IR? They will provide case data.

    Please, please take some time and learn what you are writing about. Your reputation and that of Seeking Alpha's depends on it.

    Some of the information you need to know regarding Provenge is in the Comments to this article.

    We can and most assuredly will debate the choices a free society should make when it comes to health care. But for that debate to begin requires all parties be knowledgdable in the facts under discussion.

    Ted
    Feb 7 08:52 AM | 2 Likes Like |Link to Comment
  • Dendreon Gains Will Be Short-Lived [View article]
    First, you don't know whether or not you are going to live 4 months. This seems to be the classic error made by reporters and others who simply do not comprehend what the trial statistics and FDA approval data are saying.

    I will say it once again (though somehow, I doubt this will be the last time): The median life extension benefit to Provenge is 4.1 months (though recent published studies that account for the crossover in the Placebo cohort place place the life extension benefit at 7.8 months to slightly over 12 months). That 'homeless person' you so willingly eager to condemn to an early death might live 7 or 8 years more, as some Provenge recipients have done.

    You, sir, appear to want to set up death panels and adjudicate the worthyness of a person to society as if their were a dog who should be put down because he 'deserves to be put out of his misery.'

    Or is it that this homeless person should be 'put down' so that he can be put out of 'our' misery because of OUR having to take care of another human being?

    Please! Don't check your humanity at the door as some in this country would appear to be doing.

    Ted
    Feb 7 08:43 AM | 2 Likes Like |Link to Comment
  • Dendreon Gains Will Be Short-Lived [View article]
    I won't argue your point about having a national discussion regarding health care, Dana. I'm more concerned about why you chose to focus on Provenge when it is not the most expensive treatment on the landscape. I'm also concerned about the errors in your presentation.

    Ted
    Feb 7 08:31 AM | 3 Likes Like |Link to Comment
  • Dendreon Gains Will Be Short-Lived [View article]
    The spelling error was mine.* I accept full responsibility for it. In this case, it was a matter of 'quick fingers.' That said, bad spelling is a curse under which I have labored for years, and even Bill Gates has provided little help in some instances.

    Ted (;>)

    *As for repetition of certain postings in this discussion, they derived from postings I placed on the AP site following an article published yesterday, in which that news (sic) organization failed to do its homework as well. You can see my two postings here:

    FDA questions Amgen drug for prostate cancer

    http://yhoo.it/yP32PG
    Feb 7 08:23 AM | 2 Likes Like |Link to Comment
  • Dendreon Gains Will Be Short-Lived [View article]
    akcje,

    That's absurd: 'So let me repeat again: " median IS average. There are many ways to measure average, like median, arithmetic mean, geometric mean, mode, etc..."'

    I did not read further. Please come back after you have read a basic text on mathematics and understand what's going on here. Then, we can have a rational discussion of the facts related to the Provenge trials.

    As for repetition of certain postings in this discussion, they derived from postings I placed on the AP site following an article published yesterday, in which that news (sic) organization failed to do its homework as well. You can see my two postings here:

    FDA questions Amgen drug for prostate cancer

    http://yhoo.it/yP32PG

    i said it above, and I will say it again: "If you want to have a debate, at least get your facts straight."

    Finally, for the record, I'm willing to state who I am, my background, and where I stand. Who are you? Why should anyone listen to you? Upon what bases can anyone decide your credibility?

    Ted
    Feb 7 07:15 AM | 2 Likes Like |Link to Comment
  • Dendreon Gains Will Be Short-Lived [View article]
    This article is an aberration. I really am scratching my head. The number of errors is unbelievable.

    The [writer] doth protest too much mee thinks
    (Queen, in Hamlet (Quarto 2) 3.2;
    with apologies to Wm. Shakespeare)

    Ted
    Feb 6 08:47 PM | 3 Likes Like |Link to Comment
  • Dendreon Gains Will Be Short-Lived [View article]
    Confusion?

    With all due respect, sir, YOU are the one who is confused!

    If you want to have a debate, at least get your facts straight.

    The FDA's approval was based on a median (NOT average) life extension benefit of 4.1 months. (No, Provenge is not a cure...there is none at this time...but it does provide a life extension benefit.)

    That means that while half of all patients in the pivotal Phase 3 trials experienced a life-extending benefit of less than 4.1 months, half of the men had their lives extended by a longer period of time, some up to 7 to 8 years.

    Further, recent analyses indicate that because of crossovers in the placebo arms of the pivotal Phase 3 studies (that is, where patients in the placebo arms crossed over and were given a frozen form of Provenge (called 'Frovenge'), the final results were distorted in such as way that the TRUE median life extension benefit to Provenge probably lies somewhere between 7.8 and 12.1 months. This is considered absolutely astounding by the medical community for end stage prostate cancer victims.

    Specically, the median survival of patients in the Provenge Phase 3 pivotal trial were as follows: Those in the "placebo" cohort had a median survival of about 21 months, and those on Provenge had a median survival of a little over 25 months, yielding the approximate 4-month median survival benefit that was used for FDA approval. Some useful data points from the study:

    1) After 1 year, the survival rate was 80% for Provenge and 72% for placebo.
    2) After 2 years, the survival rate was 37.8% for Provenge and 32.2% for placebo.
    3) After 3 years, the survival rate was 14.5% for Provenge and 11.1% for placebo.
    4) After 4 years, the survival rate was 4.1% for Provenge and 2.3% for placebo.

    Instead of talking about a 4.1-month median survival benefit/advantage (which some people can’t understand), perhaps it would be better to talk about a 38% improvement in 3-year survival and/or a 22.5% improvement in risk of dying.

    Or put another way, the pivotal IMPACT trial of Sipuleucel-T (Provenge) showed an extension of 4.1 months median survival time in the treatment arm beyond the control arm.

    Further, the odds of a patient treated with Sipuleucel-T surviving at 3 years was about one in three comparing to the odds of about one in five for an untreated patient. This level of efficacy coupling with a mild side effect profile [mild flu-like symptoms] was remarkable when compared to the current standard of care, the chemotherapy Taxotere, which showed only a 2.5 months median improvement with possibly debilitating side effects.

    Finally, the full Provenge treatment (in its entirety (three infusions)) costs $93,000, but it is hardly the most expensive treatment on the market. Zytiga (which must be taken with prednisone and which has a median treatment length of 8 months) costs $72,000 per year (if annualized), so costs can rise significantly. Similarly, Revlimid costs $91,000 per year and may be taken as maintenance therapy for several years. Avastin can cost up to $100,000 per year. A bone marrow transplant can cost $250,000. So, stop the nonsense of using Provenge as the whipping boy for high-cost treatments.

    You call me a bull for Dendreon. Yes, I own the stock and I believe in the science. To that end, I have educated myself and strive to inform those to whom I address myself.

    I demand nothing less from others on Seeking Alpha.

    Ted
    Feb 6 08:14 PM | 14 Likes Like |Link to Comment
  • Dendreon And Provenge's True Median Life-Extension Benefit [View article]
    I'm not going to speculate on that, rd. But I wish you well with your strategy.

    Ted
    Feb 5 09:54 AM | Likes Like |Link to Comment
  • Vical Inc.: A $3 Biotech Lottery Ticket I Am Buying Now [View article]
    Good old Adam. Still shilling for his hedge fund buddies.

    I like this response from MyDisqusID2 (1 week ago )

    Obviously, not everyone agrees with you on Vical (http://bit.ly/yoZrOP....

    Specifically, regarding your (?...your hedge fund friend’s?) statement to the effect that “[R]esults from previous Allovectin clinical trials overstate tumor response because patients enrolled in the studies were relatively less sick…,” a look at the Phase 2 trial specifications shows that the population comprised Stage III (53%) or IV (47%) metastatic melanoma patients…hardly what I would call ‘relatively less sick.’ (Slide 9; http://bit.ly/A2TcHs...

    Moreover, given the severity of this disease, it’s important to note that more than 60% of the subjects didn’t even complete more than one treatment cycle, with most of those progressing with their melanoma (there were no withdrawals for toxicity or adverse events; nor were there any grade 3 or 4 drug-related adverse events).

    Of those in the study, 11.8% achieved an objective response. The data for three cases are provided in slides 11, 12, and 13. Would you not call those serious cases? Look carefully at the extensive in-transit metastases in the right leg of the 58-year-old woman whose tumor lesions are shown in slide 13? Would you call this a ‘mild case?’

    More importantly, the patients in the Phase 3 trial should be even “less sick” than those in Phase 2, because all will be chemonaive. Plus, they’ll be able to stay on the study through 16 weeks of treatment unless they have significant disease progression. These factors should meaningfully help the Allovectin arm with both long-term response and survival. But they won’t help the chemo arm much because chemo simply doesn’t work long-term.

    I don’t know what data your friend who runs a hedge fund is looking at, but if the results of the Allovectin Phase 3 trial confirm or exceed what was seen in the Phase 2 trial showed, your friend and his investors will indeed have a serious problem.
    Feb 3 02:38 PM | Likes Like |Link to Comment
  • Vical Inc.: A $3 Biotech Lottery Ticket I Am Buying Now [View article]
    Bret,

    Excellent piece on one of my favorite stocks.

    The company is well-prepared for Allovectin launch, per my recent article below.

    Ted

    http://seekingalpha.co...

    Full disclosure: I am long VICL
    Feb 3 01:39 PM | Likes Like |Link to Comment
  • Vical's Allovectin: If Approved, What Kind Of Launch Can Be Expected? [View article]
    Good questions...and I don't have many answers. The crystal ball is still clouded at this point.

    It’s been estimated that in 2009, 68,720 Americans (29,640 women and 39,080 men) developed invasive cutaneous melanoma. Meanwhile, there were an estimated additional 53,120 cases of melanoma in situ. Advanced and metastatic melanoma will develop in about 10% of these cases.

    Source: http://bit.ly/yzApm4

    So, the US market is quite large for the targeted indication. (Don't forget the ROW agreements Vical has in place.)

    The problem I have in determining Allovectin usage is how much drug is used with each patient. Here is how the treatment was applied during the Phase 2 study:

    Select up to 10 target tumor lesions to follow
    Repeat injections into same single lesion
    Cycle = 1/wk x 6 wks + 3 wks observation*
    (*The Phase 2 study included three weeks of observation after the six-week treatment period, for a total treatment cycle of nine weeks. The Phase 3 trial includes two weeks of observation after the six-week treatment period, for a total treatment cycle of eight weeks.)
    Measure response in all target lesions.

    Presumably, treatment could continue without end, depending on the patient's condition.

    Nor do we have any information on Allovectin pricing. And, of course, we have to take into account the fact that Vical does not have 100% ownership of the revenue stream, though the royalties paid to it are in the double-digits, and escalate.

    So, it's difficult to make revenue projections at this juncture, something that you and others find troubling, and for good reasons.

    As well, how does one value the rest of the pipeline?

    I don't think we have the data needed at this time to make hard value judgements of the type you seek, but that said, I find your work interesting.

    Thanks for sharing.

    Ted
    Feb 3 08:49 AM | Likes Like |Link to Comment
  • Dendreon And Provenge's True Median Life-Extension Benefit [View article]
    Hi, rd...

    I think you meant "...better job than Dr. Gold..." LOL

    The change in management was necessary, for a number of reasons. And the BOD's choice was a good one. I don't know whether or not it impacts on the chances of a buyout. If Provenge 'has legs' and the uptake curve, as evidenced by monthly revenues in 2Q12, shows significant acceptance by the patient/provider communities, there are severall Big Pharmas who have the cash necessary to buy DNDN, be it on friendly or hostile terms. As they say, follow the money. Personalities have nothing to do with it.

    Ted
    Feb 3 08:24 AM | Likes Like |Link to Comment
  • Dendreon's Presentation At JPMorgan Healthcare Conference: 3 Things Of Interest [View article]
    i can't comment on BSR material without violating the terms of my subscription. Sorry.

    I will say, however, that MDV3100 appears to be an excellent drug in the post-chemo setting, far better than Zytiga. What I'd really like to see is a trial that involves the co-administration of Provenge and MDV3100.

    I also will point out that the physician and patient community should not dismiss lightly the 7.8 month (and possibly longer) median life extension benefit that has been demonstrated by the data described above and in earlier analyses of the Provenge trials that took into account the crossover of patients in the placebo cohort to Frovenge.

    Finally, as is the case with a number of diseases, several therapeudics will be 'layered' on to treat the problem. As such, one can assume Provenge, MDV3100, and other treatments will be sequenced or co-administered, depending on the patient's needs and the orthogonality of treatment characteristics.

    Ted
    Feb 2 04:45 PM | Likes Like |Link to Comment
  • Dendreon And Provenge's True Median Life-Extension Benefit [View article]
    Hi, WW...

    There's not other way that I know of to determine the number of authorized providers. And simply because they are 'signed' is not guarantee that they have infused patients. There obviously is a lag.

    Still, given that Wall Street now underestimates the monthly sales in the extreme, my guess is that the surprises will be on the upside. I still look for a month in late 2H12 that achieves $40M in revenue, bringing the company on an annualized basis to cash-flow breakeven.

    Ted
    Feb 1 08:50 PM | Likes Like |Link to Comment
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