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Theodore Cohen

 
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  • 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, 2012. 08:50 PM | Likes Like |Link to Comment
  • Dendreon And Provenge's True Median Life-Extension Benefit [View article]
    Hi, Bryce...

    Thanks for dropping by. To your questions:

    1. I believe the use of Frovenge was an enticement on the part of Dendreon to encourage enrollment in the study. Remember, Taxotere had been approved, and so, the idea that many in the placebo cohort might receive some benefit from a frozen form of Provenge was an appealing thought to those who were considering joining the trial. As it turned out, Frovenge worked better than had been anticipated, so much so, in fact, that it's use almost 'failed the drug,' as David Miller would say. That is, it worked so well that the K-M curves (see the figure in the article) didn't separate well.

    2. The study using a pure placebo will begin in 2013. I discussed this in my article last fall. here's the URL:

    http://bit.ly/wpaiAN

    I apologize is there was any confusion in that regard. From the previous article: "Importantly, however, near the end of his presentation, Schiffman mentioned that in 2013, the company will initiate a trial with Provenge in earlier stage prostate cancer, a trial for men who are hormonally sensitive (not castrate resistant, but where the disease has metastasized). 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."

    3. You should be able to access the abstracts by clicking on the hotlinks in my article or by reading Dendreon's press release. For more information, I would contact the authors of the papers directly.

    Ted
    Feb 1, 2012. 11:59 AM | Likes Like |Link to Comment
  • Vical's Allovectin: If Approved, What Kind Of Launch Can Be Expected? [View article]
    Hi, Retiredpharma...(it looks like you still look pretty active to me!)

    The use of a relatively safe and well-tolerated immunotherapy in earlier-stage disease certainly makes sense, but clinical trials to support such use in melanoma may be difficult to design.

    For prostate cancer, the standard of care for early-stage disease is often “watchful waiting,” and many would argue that no intervention is needed or desired if the cancer is not growing aggressively. Dendreon has been able to break through this barrier in part because of the huge population affected by this disease. Only a small percentage of willing patients is required for a sizeable clinical trial. And the prostate lobby supporting development of new treatments is very strong.

    For melanoma, the standard of care for early-stage disease is surgery, and many would argue that delaying surgery to administer several courses of immunotherapy treatment may put the patient at greater risk of further disease spread. Surgery has a high success rate, and recurrence of disease is often delayed for years or even decades. The affected population is much smaller, and the advocates are not as well-funded.

    I fear that it may take many years for this “logical” extension of melanoma immunotherapy to become accepted because there is no clear mechanism by which it can be tested in a controlled clinical trial of reasonable size and duration. Of course, I would love to be proven wrong on this point.

    Thanks for your comments.

    Ted
    Feb 1, 2012. 11:34 AM | Likes Like |Link to Comment
  • Dendreon's Presentation At JPMorgan Healthcare Conference: 3 Things Of Interest [View article]
    Hi, punjabi.

    I believe the timing is correct. Dr. Gold did yeoman service bringing Provenge through through the corrupt approval process of the FDA as well as a ridiculous Medicare nationa coverage review that wasted taxpayers' money and delayed the treatment of thousands of men suffering from PCa. Despite all of the roadblocks thrown in the company's way by the US government and Wall Street, Provenge still is one of the top ten launches in the oncology space in the United States.

    That said, it's time for him to turn leadership over to someone who can take the company to the next level. So yes, I support the change in leadership at the top.

    Ted
    Feb 1, 2012. 10:42 AM | Likes Like |Link to Comment
  • Dendreon's Presentation At JPMorgan Healthcare Conference: 3 Things Of Interest [View article]
    I don't have the data, but i suspect that if you looked at the patients who cease using Zytiga, more than a few drop out because of the need to co-administer prednisone with the drug.

    Ted
    Feb 1, 2012. 09:39 AM | Likes Like |Link to Comment
  • Dendreon's Presentation At JPMorgan Healthcare Conference: 3 Things Of Interest [View article]
    I have an article waiting for publication at Seeking Alpha.

    Ted
    Feb 1, 2012. 09:37 AM | Likes Like |Link to Comment
  • Vical's Allovectin: If Approved, What Kind Of Launch Can Be Expected? [View article]
    John,

    With all due respect, I don't believe people come to Seeking Alpha to read scientific papers. They are searching for data and information to 'instruct' their investment decisions. It is their responsibility to sift and winnow the material provided to them, to consider the sources, and to ponder their own risk tolerance before entering into any purchase decision.

    No one held a gun to your head and forced you to purchase shares in Vical. And you certainly acquired your position long before you began reading what I had to say about the company.

    The fact is, I have made money investing in Vical. I still own a significant number of shares. I still believe in their science.

    But...I have never...NEVER!...issued a BUY or SELL recommendation in any one of my articles, on Vical or any other company upon which I have commented.

    It's quite clear that you have lost money in this stock. It's also quite clear that you are not done being angry yet, and further, that you are bound and determined to make as many people's lives as miserable as possible until you 'come even' and can get out, satisfied that you have not lost money.

    The fact is, you never will break even because there's an 'opportunity cost' associated with the game you are playing. That is, while you are sitting there stewing about your losses, you could have sold your shares in Vical and invested the money, perhaps, in another company that better meets you investment goals.

    I don't think you should read anything I write. It only will make you angry. And given your attitude, I don't think anything you have to say will add to the discussion in this venue.

    Ted
    Feb 1, 2012. 07:03 AM | 1 Like Like |Link to Comment
  • Dendreon's Presentation At JPMorgan Healthcare Conference: 3 Things Of Interest [View article]
    Not a problem, DAG...comments always welcome. And yes, with DNDN, I don't think this drop is something about which to be worried...especially after the runup this month.

    Ted
    Jan 31, 2012. 04:13 PM | Likes Like |Link to Comment
  • Dendreon's Presentation At JPMorgan Healthcare Conference: 3 Things Of Interest [View article]
    This may be a normal pullback after the recent rise. There's been no news I saw that would account for the drop.

    Also, know that hedge funds report out at the end of the month, and according to one message board posting I saw (see below), these funds have suffered massive losses this month because of the rise in DNDN's price. There may be forces afoot to drive down the stock's price today in an attempt to lesson the losses they will report, and that may account for some of the downward pressure.

    http://bit.ly/wP76yQ

    That said, it's always difficult to know what accounts for the daily 'noise' in a stock's price action.

    Ted
    Jan 31, 2012. 04:12 PM | Likes Like |Link to Comment
  • Vical's Allovectin: If Approved, What Kind Of Launch Can Be Expected? [View article]
    Yes, that's correct...towards the end of the second quarter, 2012.

    Good catch.

    Ted
    Jan 31, 2012. 02:23 PM | Likes Like |Link to Comment
  • Vical's Allovectin: If Approved, What Kind Of Launch Can Be Expected? [View article]
    As I noted in the article, I think the stock still will trend lower (based on what the Weekly chart is saying). But that's only one interpretations.

    Ted
    Jan 31, 2012. 02:23 PM | Likes Like |Link to Comment
  • Vical's Allovectin: If Approved, What Kind Of Launch Can Be Expected? [View article]
    Hi, DAG!

    Nice to see you. And thanks. Everyone is holding their breath on Allovectin. But I'm confident that if approval is given, Vical will be prepared to launch.

    Be well.

    Ted
    Jan 31, 2012. 12:34 PM | Likes Like |Link to Comment
  • Immunotherapy Cancer Trials With Key Data Due In 2012 [View article]
    I'm not going to comment on herbal and vitamin treatments.

    Ted
    Jan 26, 2012. 03:57 PM | Likes Like |Link to Comment
  • Immunotherapy Cancer Trials With Key Data Due In 2012 [View article]
    Your point was, there was no shrinkage of the tumors. There was, and frankly, as begruding as it was for you to admit, I think it was 'more than a little.'

    Of course it's not proof...that's what we're waiting for.

    Ted
    Jan 26, 2012. 03:55 PM | Likes Like |Link to Comment
  • Immunotherapy Cancer Trials With Key Data Due In 2012 [View article]
    JP, further to our current debate, I did some research and would point out a few facts:

    1) The historical response rates most often reported for DTIC are “objective overall responses,” aka “best responses,” which measure the peak regardless of time element. Chemotherapy responses occur very quickly, but they almost never begin after 6 months (late onset), and typically do not last anywhere close to 6 months (duration). Allovectin responses occur more slowly, but frequently begin after 6 months and typically last more than a year.

    2) The primary endpoint in Allovectin's Phase 3 trial is objective response rate at 24 weeks or more after randomization. In the Phase 2 Allovectin study, all responders by “objective overall response” criteria were also responders at or beyond the 6 month time point. The median duration of response in the Phase 2 Allovectin study was 13.8 months, and the range was 6 to 66 months and continuing at the time follow-up was ended. There are very few papers that report “durable response rate” for DTIC in melanoma, but those that do clearly demonstrate a significant decline from the peak. I can't find any studies reporting late-onset responses for DTIC. Do you have knowledge of same? The Allovectin Phase 3 primary endpoint was designed to highlight this important advantage for patients.

    3) At ASCO 2011, you will recall, Vical presented new statistical analyses of data from completed Allovectin trials that demonstrated a strong positive correlation between response and survival. Simply put, patients who responded to Allovectin lived longer than patients who do not respond. This correlation may seem obvious, but it has not been shown for patients treated with chemotherapy. In the latter case, their tumors typically shrank but returned quickly without prolonging survival. Again, long-term benefit to patients (reduction of tumor burden AND extended survival) is the goal.

    4) Obviously, nobody knows the outcome of the ongoing Allovectin Phase 3 trial. However, if the historical results are repeated, the trial is well designed to demonstrate significant advantages for Allovectin vs. chemotherapy in both long-term response rate and survival.

    Regardless of our positions, I think we are in agreement on one point: we both eagerly awaiting the trial results.

    Ted
    Jan 26, 2012. 12:24 PM | Likes Like |Link to Comment
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