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Saul Kerpelman

 
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  • Good News for Dendreon's Provenge [View article]
    Sure. Provenge is expected by just about everyone involved to work even better in earlier stage disease. The men studied so far were the sickest of the sick and already had severely compromised immune systems. Still it was able to extend life for the largest amount ever in late stage disease. There is every reason to expect that it will have even more effect in men with stronger immune systems to prime. I believe one strong reason for the CMS review was to establish that Medicare won't have to pay for Provenge off label, which scores of men are going to want. I do hope Dendreon works with EXEL on combination therapies--but I expect that given its very benign side effect profile Provenge will soon be baseline therapy.
    Feb 19, 2011. 01:18 PM | 6 Likes Like |Link to Comment
  • Dendreon, The Fabled "Next Amgen"  [View instapost]
    That's total BS. The Provenge Impact trial was performed under an SPA with The FDA in which The FDA approved the trial design--further what you write doesn't even make sense: the control arm was not placebo, but guys allowed to cross over to frozen Provenge after their disease progressed, thus the 4.1 MEDIAN number UNDERSTATES the benefit of Provenge. Compared to the men who didn't cross over, Provenge had a 14.2 month median advantage. I sense that you are just trying to spread FUD, since your comment is ludicrous.
    Jul 13, 2010. 05:34 PM | 5 Likes Like |Link to Comment
  • Dendreon: The Challenge Of Misinformation [View article]
    Again, hard to believe you are an oncologist when you don't seem to get that it is not an either/or proposition. Provenge should be sequenced early, when the immune system is strongest, and since its effect seems to improve over time. Chemotherapy can then be given if/when the patient elects to chance its ravages for the additional smaller survival benefit. It's about stacking benefits to gain years instead of months. But then of course you already know that, being an oncologist and all.

    Way too many fake doctors here IMO.
    Sep 2, 2011. 08:42 PM | 4 Likes Like |Link to Comment
  • Dendreon's Golden Age Is Still On Track [View article]
    The company just last month received a "Q code" for Provenge. This allows for computer processing of claims and a much quicker turnaround time. Docs I have talked to are being reimbursed in less than 30 days. Once word of that spreads there is a good chance Dendreon will get right back on track.

    IMO a big buying opportunity here.
    Aug 29, 2011. 03:14 PM | 4 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 Is Way Undervalued [View article]
    I think you have your facts wrong. They are actually conducting a phase three trial right now--P-11--that is assessing Provenge use in men who have not yet had their prostates out. It doesn't attack the prostate--only cells expressing the antigen that is used in Provenge, and that antigen is expressed in >90% of prostate cancer cells. There was a concern that there might be a problem with attacking healthy cells, since there are some healthy cells that express PAP, the antigen, but it hasn't happened that way. Early results showed that Provenge slowed PSA doubling time significantly. The study is also tracking progression and survival and results next year may be a step toward Provenge being recognized for use in earlier stage disease--a >10 billion dollar market.
    Apr 22, 2011. 09:06 AM | 4 Likes Like |Link to Comment
  • Why Dendreon Will Power Ahead Now [View article]
    Actually I do know Medicare very well--I was at the MEDCAC panel they held on Provenge and have read all the applicable statutes.

    No one is counting chickens--Dendreon is going to meet its guidance and the share price will appreciate accordingly.
    Mar 31, 2011. 05:41 PM | 4 Likes Like |Link to Comment
  • Good News for Dendreon's Provenge [View article]
    Yes, as above the expectation is that it will work even better in earlier stage disease. The company is running trials in earlier stages and just announced in January that they will be starting a new global study in M1 in the near future along with their European expansion plans.
    Feb 19, 2011. 01:27 PM | 4 Likes Like |Link to Comment
  • Good News for Dendreon's Provenge [View article]
    But of course your disappointment is based upon the faulty premise that the absolute limit of Provenge's life extension is 4.1 months--which any true scientist would realize is just blind "statistical purity" rigidity such as denied Provenge to dying men (including your Dad?) who could have had the treatment 3 years ago. Why do you also discount the treatment as a breakthrough? Provenge validates the approach and the company is starting a trial in bladder cancer. Seems like maybe you have some anti-Provenge agenda.
    Feb 19, 2011. 01:24 PM | 4 Likes Like |Link to Comment
  • Dendreon, The Fabled "Next Amgen"  [View instapost]
    You are obviously pretending to have knowledge you don't really have to protect whatever option position you have taken. When is the FDA going to "look at it"? Provenge is already approved by the FDA, which approved the study design. No one in the study "lost T cells"--whatever that is supposed to mean. The therapy trains and activates antigen presenting cells, which are then reinfused and IN THE PATIENT induce a massive T cell response. Just like your bud who posted similar junk earlier, you don't know what you're talking about, and frankly you're not even good at pretending you do.
    Good luck.
    Jul 14, 2010. 04:10 PM | 4 Likes Like |Link to Comment
  • Dendreon: The Challenge Of Misinformation [View article]
    None of us knows whether you actually have cancer or not. If you do I'm sorry for you, but that doesn't let you off the hook for making bad arguments. You say you reject Provenge as too expensive for "a few extra months" but, first, you are not on label yet, and second, you just ignore the whole point of my article, which is that with almost no side effects Provenge might give you years of extra life. Once you are a candidate I assume the same carrier that paid for all your other treatments will pay for Provenge too. When you obviously have insurance it is disingenuous for you to talk about bankrupting your family. What's with that? Also why do you ignore the fact that Provenge's hazard ratio indicates a 22.5% reduction in the risk of death? You also keep referring to "better" treatments while ignoring that Provenge is the FDA approved treatment with the best benefit ever. Prostvac results were P2 and are very suspect. Why do you think BavarianNordic can't find a partner? Lastly your referral to "koolaid" seems kind of like a tip off to me that you have more of an investor's agenda than a patient's agenda. I kind of think a true cancer patient would be happy that life extension from Provenge might be in his future rather than being so hostile and attacking the Provenge results. The biggest names in cancer research hail it as a major breakthrough. Why noy you? Smells funny to me. Sorry. Others can judge for themselves.
    Sep 4, 2011. 09:46 PM | 3 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 Learns From ICOS' Mistake [View article]
    "efficacy is weak at best"--you've got to be kidding. Provenge improved three year survival by 40% and that was comparing Provenge to Frovenge, the frozen salvage product, which it turns out confers its own survival benefit. Even as it is Provenge has the greatest survival benefit in this population EVER. You obviously have some agenda or simply are ill informed. Provenge is just the start in a cancer treatment sea change--and Dendreon owns the whole thing.
    Apr 6, 2011. 08:45 AM | 3 Likes Like |Link to Comment
  • Why Dendreon Will Power Ahead Now [View article]
    Don't think so. The market cap is way too low if you price in 2 Billion in revenue in 2 years. Usually cancer biotechs with new drugs get a multiple of 6 to 8 times revenue for their reasonable market cap.
    Mar 31, 2011. 05:43 PM | 3 Likes Like |Link to Comment
  • Dendreon: The Big Push on Provenge Begins [View article]
    Great article, Larry. I think you should also point out that the Dendreon plants to manufacture Provenge are atypical in another way as well: Cost. Where the usual recombinant protein plant can cost hundreds of millions and, as you say, take years to build and get approved, Provenge "factories" are really just warehouses with dozens of drop in, standard lab "clean rooms", and cost somewhere between 50 and 70 million total, depending on the number of work stations or "hoods" (in biotech parlance). Then each cheap factory can produce Billions worth of product for years.

    I have heard rumors for the past year about future plants in the Chicago area and in Texas. Do you have any information on this?
    Feb 22, 2011. 01:35 PM | 3 Likes Like |Link to Comment
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