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Saul Kerpelman

 
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  • Dendreon: The Challenge Of Misinformation [View article]
    You're pretty relentless, I'll grant you that. Still, most of your arguments are totally fallacious. Do you not take aspirin because they don't yet know its exact method of action? They've been trying to figure that one out for about a hundred years now.

    Seems pretty obvious a guy with PC who is on label for Provenge would be foolish not to try it--best survival advantage ever, almost no side effects, and could extend life for years.

    Don't know exactly why you're arguing against it so hard, but that seems like a very easy decision to me--for both the doctor and the patient.
    Aug 29, 2011. 03:08 PM | Likes Like |Link to Comment
  • Dendreon: The Challenge Of Misinformation [View article]
    The FDA makes it hard for a company to defend itself from misinformation like this. They impose standards that require them to only mention pre specified study endpoints and bar them from providing the background data to the public.

    For instance, Provege was not tested against placebo, but against frozen Provenge after the men progressed. Frozen Provenge seems to confer it's own survival advantage--so the trial results likely understate the benefit of Provenge. The FDA won't let Dendreon tell patients this, even though for sure they would want to know it when making decision.

    Fear of "false claims" makes the FdA prohibit the flow of relevant important information.
    Aug 29, 2011. 11:36 AM | 1 Like Like |Link to Comment
  • Dendreon: The Challenge Of Misinformation [View article]
    That's just not true Robert. The FDA approved it based upon rigorous scientific requirements. Survival is the gold standard endpoint and Provenge increases survival.

    Sure they should continue to study how it achieves this, but in the meantime there's no excuse for a doctor not to prescribe it.
    Aug 29, 2011. 11:27 AM | 2 Likes Like |Link to Comment
  • Dendreon: The Challenge Of Misinformation [View article]
    Thanks Ted.
    Aug 29, 2011. 07:57 AM | Likes Like |Link to Comment
  • Dendreon: Profits Ahead as Provenge Gets Reimbursement Approval From Medicare [View article]
    I don't really believe you are a medical oncologist--or if you are you are one who doesn't really understand statistics. The "few extra months of life" line is the giveaway. The median is the number when half of patients died. By definition half lived longer than that. Many men lived many extra years. There was a 40% improvement in 3 year survival. As to taking market share, you don't get that either--men will wind up getting sequenced therapies. It's not either/or.
    Aug 19, 2011. 09:45 AM | Likes Like |Link to Comment
  • Dendreon: Profits Ahead as Provenge Gets Reimbursement Approval From Medicare [View article]
    What you say is true about averages, but I think that's why the 3 year survival is more telling. In each of the studies the three year survival of the treated men was at least 40% better. In 9901 I seem to remember it was 33% vs. 11%. That's not averages, it's raw numbers of men making it to three years. And the treatment group always has blown away the Frovenge group. In 9901 only one "pure placebo" guy made it to 3 years.

    Something is happening there, even if it's not apparently affecting progression as progression is currently measured. Progression in PC is a messy endpoint anyway--too subjective and hard to define. Guys live a lot longer--that's the Gold Standard.

    Easy to hypothesize they'll live even longer if treated earlier with healthier immune systems.
    Aug 19, 2011. 09:39 AM | Likes Like |Link to Comment
  • Dendreon: Profits Ahead as Provenge Gets Reimbursement Approval From Medicare [View article]
    I fully realize that the data are only hypothesis generating and that they weren't matched sets--still even the NEJM article noted the survival difference and the Duke analysis aimed to at least rule out the confounders that could be--and suggested that Frovenge may very well have produced a survival advantage of its own. Just saying it looks like the advantage is more than 4 months at median.
    Aug 18, 2011. 10:29 PM | Likes Like |Link to Comment
  • Dendreon: Profits Ahead as Provenge Gets Reimbursement Approval From Medicare [View article]
    I don't understand the hang up about not stopping tumor progression. In such late stage men it seems to me that that is really asking for a lot. If it helps extend life significantly, why obsess about what it doesn't seem to do that is less important? Also I don't understand the being stuck on four months. Many men did live many years longer and 3 year survival is improved by 40%. I know you say only 32% versus 23%, but again the 23% was not "placebo" but men who got Frovenge--which seems to perhaps have its own survival advantage by the Duke analysis.

    Wait for P-11 results on delay in distant mets--if that is stat sig I believe Provenge will get a Compendium listing in earlier stage disease. Then you'll be convinced, right?
    Aug 18, 2011. 10:25 PM | Likes Like |Link to Comment
  • Dendreon: Profits Ahead as Provenge Gets Reimbursement Approval From Medicare [View article]
    So your answer is to castrate the men even more, rather than attempt instead to have the immune system kill the cancerous cells?

    What about the potential to use Provenge in earlier disease, when the immune system is healthier? I doubt there's any chance abi will make Provenge obsolete. Should be the other way around--if the cancer can be controlled at an earlier stage there may be no need to castrate.
    Aug 18, 2011. 08:40 AM | Likes Like |Link to Comment
  • Dendreon: Profits Ahead as Provenge Gets Reimbursement Approval From Medicare [View article]
    That's a 40% improvement in 3 year survival. Not 40% survival at 3 years. Still, those numbers are deceiving because the 23% survival for "placebo" includes guys who got frozen Provenge. In the earlier 9901 study only one patient who was pure placebo, not Frovenge, made it to 3 years. In Impact the survival advantage of Provenge over pure placebo men who elected not to crossover after disease progression was more than 14 months. It's not a "small" survival advantage.
    Aug 18, 2011. 08:37 AM | Likes Like |Link to Comment
  • Dendreon: Profits Ahead as Provenge Gets Reimbursement Approval From Medicare [View article]
    As I've told you Robert, I'm waiting to see the plan before deciding where I stand as to "Dump Gold". I will say if the plan does not include firing him, he should reduce his salary to $1 and forego any further option grants until things improve--and cancel all his planned sales. Also should buy shares in the open market to show faith in the plan.

    Once I see the plan, I'll write more on this issue.
    Aug 16, 2011. 07:31 PM | 2 Likes Like |Link to Comment
  • Dendreon: Profits Ahead as Provenge Gets Reimbursement Approval From Medicare [View article]
    "Marginally efficacious"? You're joking right? Actually I know you're not, but that comment outs you for what you are--charitably, an intentional spreader of incorrect information.

    Provenge had the largest survival advantage ever for this population--and it attained that with one hand tied behind its back--so to speak--since it looks like the "placebo" group actually got a survival benefit from the frozen Provenge they got. The true median advantage could be as much as 14 months and surely is somewhere north of the 4.1 months reported in the Impact study.

    None has yet reached P3, but they are starting a P2 study in bladder cancer this year for the next product.

    What exactly is going to make it obsolete? It is a breakthrough and the Holy Grail of cancer research--teaching the body to fight cancer.
    Aug 16, 2011. 07:26 PM | 4 Likes Like |Link to Comment
  • Dendreon: Profits Ahead as Provenge Gets Reimbursement Approval From Medicare [View article]
    Long term I believe these treatments will be very cost effective. How much is spent treating cancer? How much could be saved if cancer could instead be prevented or treated early enough to wipe it out?

    Even in today's environment Provenge is not any more expensive than other cancer drugs when you account for all the extra money that is spent treating/managing the horrible side effects of chemo. Provenge side effects are a day or two of chills and fever.

    Most importantly, since it boosts the immune system it is logical to expect that it will work even better in earlier stages of the disease--before the immune system has been weakened.
    Aug 16, 2011. 10:28 AM | 3 Likes Like |Link to Comment
  • Dendreon Is Way Undervalued [View article]
    They are ramping up a new product. You can't look at revenue per share in that situation. That 48 Million was produced by one tenth of their capacity and even that took a while to get to max after approval. Next year they will have 120 work stations vs. 12 this past year. In the 4th Q this year they are guiding for making almost 200 Million and next year should have a Billion annual run rate. The normal metric is to multiply revenue by the multiplier and that gives a reasonable market cap, i.e. 7x1 billion=market cap of 7 Billion. If Provenge hits 4 Billion on label, as many predict, that would justify a market cap of 28 Billion. That's a share price of almost 200.
    Apr 27, 2011. 08:39 AM | 2 Likes Like |Link to Comment
  • Dendreon Is Way Undervalued [View article]
    Read my earlier article about provenge. 30,000 men die of pc each year. Over 200,000 are diagnosed. It is the second most common cancer. Even if only 3% die wouldn't you want provenge if you were diagnosed and with almost no side effects it could perhaps cure you? Late stage market alone could be 4 billion globally and early stage 10 billion.
    Apr 22, 2011. 08:39 PM | Likes Like |Link to Comment
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