Seeking Alpha

Theodore Cohen

View as an RSS Feed
View Theodore Cohen's Comments BY TICKER:
Latest  |  Highest rated
  • Dendreon Shareholders May Yet Have The Last Laugh [View article]
    Super!

    As I understand it, DNDN is being much more careful, these days, qualifying providers. More than ever, it's a concern for the 'quality' of the providers...that is, whether or not they can deliver the patients.

    I'm also seeing the Provenge providers distinguishing themselves in the marketplace as "21st Century Providers of Medicine." Which is interesting, because in one fell swoop, they have repositioned their competition--the non-Provenge providers--into the 20th Century (i.e., the Dark Ages of medicine!).

    Here's the best example I know of how to reposition your competition OUT of your space. When Richardson-Vicks developed Nyquil, the last thing the world needed was another cold medicine. What did they do? They marketed it as The Nighttime Cold Medicine. Immediately, everyone thought of their competition as being for the daytime, and Nyquil had the nighttime market to itself (at least for quite some time).

    If those providing Provenge portray themselves as practicing 21st Century medicine, then anyone that doesn't offer Provenge as an option to those suffering from PCa will (should) be viewed as practicing 'their father's medicine.' Believe me, people talk among themselves (come to my gym and listen to the conversation!). It won't take long befor those who don't provide up-to-date treatments, much less understand them, see their patients voting with their feet.

    Thanks for stopping by.

    Ted
    Sep 30 03:13 PM | Likes Like |Link to Comment
  • Vical's Allovectin-7: Are The Phase 3 Trial Results Hiding In Plain Sight? [View article]
    Thanks, GG.

    I hope people listen to the interviews on the Vical Web site. The CEO is quite candid about the risks in this trial.

    This disease is the graveyard for therapies. Mederax's drug (now BMS', because they bought them out) barely made it through the gate. In fact, if I recall, the response was slightly under 10%, which was the threshold for approval. But with few options, even having this treatment available is a godsend. Only a fool wants any trial to fail because it means patients will continue to face a bleak future.

    Ted
    Sep 30 02:23 PM | Likes Like |Link to Comment
  • Vical's Allovectin-7: Are The Phase 3 Trial Results Hiding In Plain Sight? [View article]
    Hi, tredleon.

    Good observations.

    I doubt seriously that anything is being communicated back to Vical. I'd be more worried about what is being communicated to others on the Street. In these days of leaks through 'expert networks,' anything is possible. Such communications, or course, are prohibited, and with the US Attorney for the Southern District of New York (Hon. Preet Bharara) on the warpath against insider trading, if someone were to be found leaking such data and were to be reported under the new SEC Whisperblower Act, there would be hell to pay. In fact, while I have not seen anything in the news recently, there was an indication some weeks ago that Bharara was about to unleash his forces in a new assault on expert networks. One can hope that this time, he will be going after those serving the medical community.

    http://1.usa.gov/pzhx5R/

    http://1.usa.gov/mXiZB7

    Thanks for your interesting observations.

    Ted
    Sep 30 01:50 PM | Likes Like |Link to Comment
  • Dendreon Shareholders May Yet Have The Last Laugh [View article]
    I certainly understand your frustration, WW. But workers kvetch everywhere, and on the Internet, where few use their real names (especially on the board you mentioned), people vent 24x7 with little if any restraint.

    Yes, we are shareholders, but the corporation is only required to inform us of 'material events.' As 'material' as we might think monthly sales numbers are at this point (and believe me, I want to see them as much as do you), there is no way the SEC or any court would agree that these numbers are something the corporation is obligated to release. Quarterly? Yes, and it may be that we will have to wait. But one can hope that Gold, et al., will find a way to drop the monthly information on us at some point if for no other reason than to kickstart the process of rebuilding their trust on the Street and among shareholders.

    Take care.

    Ted
    Sep 29 06:12 AM | Likes Like |Link to Comment
  • Dendreon Shareholders May Yet Have The Last Laugh [View article]
    I agree. On the other hand, the company can't give the appearence of being a slave to Wall Street's every whim (though we both know that the management teams of all listed companies keep their eyes on the Street).

    If Gold wants the Street (and us) to know the numbers, he'll find a way to drop them. His first priority, however, is to enhance shareholder value, and right now, the board of directors better be holding his feet to the fire!

    Ted
    Sep 28 07:32 AM | Likes Like |Link to Comment
  • Dendreon Shareholders May Yet Have The Last Laugh [View article]
    BTW, it's easy to count the number of Provenge providers (though it does take a little time). Simply go to this site:

    http://www.provenge.com/

    Put in your ZIP code, and then, keep hitting "Next 5 Results." Just count the number of sets of five providers, plus the remainder, and you'll have the number of providers.

    The count as of today is 664.

    Ted
    Sep 27 04:36 PM | Likes Like |Link to Comment
  • Dendreon Shareholders May Yet Have The Last Laugh [View article]
    Good morning.

    First, that piece by Adam is a good example of what Big Pharma and the marketing departments can do with the press. And I'm not sure that Bayer's new treatment is G_d's gift to PCa patients that some made it out to be. According to a doctor I know, RA223 is an alpha enmitter. It substitutes for Calcium in bone. Prostate cancer involves bone and bone marrow. The alpha emitter (at the level used) doesn't penetrate far enough into marrow spaces, so it won't kill the prostate cancer. Further, median overall survival was only increased by 2.8 months. ("Median overall survival was 14 months for Alpharadin-treated patients compared to 11.2 months for patients in the placebo arm.") So, while there are findings that are significant ("Apharadin significantly delayed the time to first skeletal related events in patients by 5.2 months (13.6 months compared to 8.4 months) and also decreased reports of bone pain."), I wouldn't break out the bubbly just yet.

    http://bit.ly/ozXDDq;amp

    One other thing I found extremely interesting from Adam's blog was this:

    "The emergence of Alpharadin complicates and may even block efforts by Amgen(http://bit.ly/n79wlt) and Exelixis(http://bit.ly/r4O0Nz) to advance their respective prostate cancer drugs."

    Bottom line: I'm not concerned at this point about this treatment's threat to Provenge.

    I'm not going to say anything now about my upside expectations. I want to see how the revenues grow over the next 4-6 months as the company executes its recovery plans and new commercial providers are brought onboard. As best I can tell, the number of providers is up more than 10% from early August, and there currently are 21 career openings across all of the corporation's locations. So what evidence there is to be found suggests things are going in the right direction.

    Be well.

    Ted

    PS You might also want to look at this post I found on Investor Village:

    http://bit.ly/q5FezI;mn=419073&pt=...

    Provenge is indicated for asymptomatic or minimally symptomatic CRPC (absence of Level 4 pain or use of opioid pain relievers) while Radium-223 is indicated for symptomatic ("symptomatic" not defined in presentation info).

    As a competitor: Provenge results in a 4.1 month advantage (90+% included bone metastases and 50%+/- patients included bone-only metastases) vs. 2.8 months for Radium-223 (all were bone-only metastases).

    Visceral (soft tissue) metastases is universally acknowledged as being harder to treat and having lower survival probability. Thus the interim survival benefit of bone-only treatment would seem to be skewed in favor of Radium-223.

    Appendix B1 (pg. 57--see link below) also displays that Provenge had its strongest effect on the subgroup of bone-only (<10 incidents of) metastases (16 subgroups listed). It would therefore seem clear that OS for bone-only metastases resulting from treatment for prostate cancer with Provenge would be much higher if it was targeted solely on these bone metastases occurrences.

    Provenge inclusion/exclusion criteria (See Appendix Table A1-- pg 50): http://go.cms.gov/pSbnG2

    T
    Sep 27 10:01 AM | Likes Like |Link to Comment
  • Dendreon Shareholders May Yet Have The Last Laugh [View article]
    Thanks, Slonger.

    I've owned the stock since 2006. Bought some here, sold some there. Still long. It's been a hellava ride.

    Be well.

    Ted
    Sep 27 07:25 AM | Likes Like |Link to Comment
  • Dendreon Shareholders May Yet Have The Last Laugh [View article]
    I would not be worried. These pop up all the time. Several law offices are trolling for lead plaintiffs at this time, with the clock about to run out. (I saw an advertisement last week from one firm.) If more than one plaintiff signs up with different firms, a judge, if the suits are sent forward, will combine them, with one firm taking the lead. I'd say there's a 50-50 chance this will go forward. That said, it will be years before there's a decision in the matter, and what decision is forthcoming will be covered by Dendreon's insurance company. As always, the lawyers will make out better than the shareholders. But the impact on the stock--best, worst, and most likely--will be minimal, if it has any impact at all. I'm not losing sleep over it.

    Ted
    Sep 26 11:43 AM | 1 Like Like |Link to Comment
  • Dendreon Shareholders May Yet Have The Last Laugh [View article]
    The numbers are indeed sobering.

    As you know, David Miller (see reference in my article) demonstrated that the costs of treating end stage PCa with chemo and Provenge are much the same when you take into account the necessity of treating the side effects of chemo. So, patient-for-patient, 56 patients treated with chemo (Taxotere) would cost about as much to treat as would 56 patients treated with Provenge.

    I have said many times, we all would like to pay 10 cents for our pills. That's the price of the second tablet. Unfortunately, the first one can cost billions (which is what Dendreon spent bringing Provenge to market).

    There are no easy answers here. Provenge is hardly the most expensive cancer treatment on the shelf. We can hope, however, that as the pharaceutical industry and the FDA gain experience with immunotherapies, the time to approval, and hence, the cost of development for these therapies, might drop, and with that, the cost to the patient.

    Ted
    Sep 26 08:57 AM | Likes Like |Link to Comment
  • Dendreon Shareholders May Yet Have The Last Laugh [View article]
    For clarity, readers should know the following regarding SGEN's Adcetris (which is NOT intended for the treatment of prostate cancer):

    ----------------------... AND USAGE ----------------------...
    ADCETRIS is a CD30-directed antibody-drug conjugate indicated for:
    • The treatment of patients with Hodgkin lymphoma after failure of
    autologous stem cell transplant (ASCT) or after failure of at least two
    prior multi-agent chemotherapy regimens in patients who are not
    ASCT candidates (1.1).
    • The treatment of patients with systemic anaplastic large cell lymphoma
    after failure of at least one prior multi-agent chemotherapy regimen
    (1.2).
    These indications are based on response rate. There are no data available demonstrating improvement in patient reported outcomes or survival with ADCETRIS.

    http://bit.ly/oaQDVH

    http://bit.ly/raWVtH

    As to the price of this drug, the following article informs us:

    Seattle genetics new blood cancer drug Adcetris comes with a hefty price tag
    Published on August 23, 2011 at 4:27 PM· No Comments
    inShare.

    By Dr Ananya Mandal, MD

    Seattle Genetics Inc's new blood cancer drug Adcetris is will come with a price tag of $100,000 for a course of treatment. The U.S. Food and Drug Administration on Friday gave its nod to Adcetris, the first drug specifically indicated for anaplastic large cell lymphoma (ALCL) and the first one approved for Hodgkin's lymphoma since 1977.

    Seattle Genetics on Monday said the drug will cost $4,500 per vial. In its clinical trials, the company said, patients on average received three vials per dose and between seven and nine doses per treatment. The total price would then generally vary from $94,500 to $121,500 per patient.

    For Adcetris, however, the patient population is generally younger and so more likely to rely on private insurance than federal programs, making the price tag less controversial, analysts said. About 9,000 Americans a year are diagnosed with Hodgkin's lymphoma and 3,000 with ALCL. Adcetris is the first drug approved by the FDA for Hodgkin lymphoma in more than 30 years and will provide a new therapeutic alternative for patients with limited treatment options.

    http://bit.ly/nATmSV

    My point in using SGEN's drug as an example in my article was to point out that the FDA has recently approved drugs that can cost significantly more than Provenge. Yet, compared to the stink raised last year over the price of Provenge, very little has been said in the press and on the Internet regarding the price of Adcetris and other recently approved high-priced drugs. Nor has CMS conducted a formal review (i.e., national coverage decision, of NCD) of these other drugs, as they did in the case of Provenge. Which raises some interesting questions of and by itself.

    Ted
    Sep 24 06:24 PM | 1 Like Like |Link to Comment
  • Dendreon Shareholders May Yet Have The Last Laugh [View article]
    Thanks for your comments, Miljenko.

    I have my doubts that Adcetris will provide a 'cure' (in the true sense of that term) or that we are at the point where PCa will become a chronic disease (as now is the case with AIDS/HIV). But we can hope to extend men's lives with treatments that also provide a higher quality of life.

    I'm not sure where you found your data on Provenge ("...extend average (miserable) life for 2-3 months..."), but my sources gave me the following:

    The chart showing percentage survival as a function of time for the study patients on Provenge is freely available at http://bit.ly/p7BugE...;

    Some useful points from that:
    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.

    I think if you ask any person who has been given Provenge they will tell you the side effects compared to other therapies are minimal. Make no mistake, PCa is a devastating disease. There is no reason to make the situation worse by treating it with therapies that are both toxic and devastating to the immune system.

    Thanks so much for stopping by.

    Be well.

    Ted
    Sep 24 04:45 PM | 1 Like Like |Link to Comment
  • Dendreon Shareholders May Yet Have The Last Laugh [View article]
    Hi, Pinky. And thanks for your observations and comments.

    My wife and I just returned from watching the movie Moneyball starring Brad Pitt.

    http://bit.ly/qj6wGi/

    We thought it was a wonderful movie on a number of levels. But relevant to the discussion here, I would note that late in the film, the G.M. of the Boston Red Sox says to Billy Beane (the 'hero'): “The first person through the wall always gets bloody.” He goes on to talk about how entrenched forces will fight tooth and nail to preserve the status quo.

    http://bit.ly/qTMiB3

    Which is exactly what we saw happen to Dendreon as that corporation attempted to bring Provenge to market in the face of the so-called Chemo Cartel.

    Arguably, the data Dendreon presented to the Provenge Advisory Committee on March 29, 2007, were not sufficient to support approval on May 8, 2008. (Conditional approval with a Phase 4 would have extended thousands of men's lives!) And I could have lived with the decision by the FDA to require additional data except for the fact that there were, and still to this day are, an extensive list of unexplained events surrounding the AC and a multitude of aberrant events that followed this meeting, including the meeting called at the FDA immediately following the AC to discuss Dr. Scher's letter to Dr. von Eschenbach; the copy of Dr. Scher's letter that was found on the NCI computer of Dr. Alison Martin; the three leaked letters from Drs. Scher, Hussain, and Fleming to The Cancer Letter; the $440 million co-development deal signed by Novacea and Shearing-Plough for Novacea's Asentar just three weeks after the May 8, 2008 rejection of Dendreon's NDA by the FDA (recall the Dr. Scher of MSK was co-lead on the Phase 3 trial of Asentar,* which would have competed with Provenge in the PCa space); the fact that the founder of ProQuest Investments of Princeton, NJ, sat on the BOD of Novacea at that time (and that ProQuest owned more than 8% of Novacea at the time of the Provenge AC); the Bear Raid of April 28, 2008; and the like. You can find the entire sordid story at the URL below:

    http://bit.ly/pBsDWm

    The issue of the Bear Raid was the subject of an SEC IG and Enforcement Division investigation demanded by Sen. Chuck Grassley. Based on information recently released under FOIA, it appears that there is an ongoing investigation into this matter (whether of a civil or criminal nature is not known). You can read about it here:

    http://bit.ly/oHRJMg/

    As Lucille Ball used to say, "Someone has some 'splain' to do." So, yes, lots of people talk 'conspiracy.' But the fact is, lots of things haven't been explained, and now, it appears, the SEC (or some other arm of the government (DOJ/FBI?) is taking an interest in the manipulation of Dendreon's common stock.

    And yes, wouldn't it be nice if instead of attacking Provenge at every chance, the medical and investment communities would give recognition to the fact that a new age is dawning in the treatment of one of Man's most dreaded diseases. On the other hand, so-called 'journalists' play a different game. All they seek is conflict and controversy...anything that will create readership and generate 'hits' to their Web pages. In Hearst's time, they called it Yellow Journalism. What we have today is nothing less and nothing more than the modern-day equivalent. And with Provenge being 'a first,' there's plenty of grist for their mills. As was quoted above: “The first person through the wall always gets bloody.”

    Some day, despite all that has happened, I wouldn't be surprised if someone associated with the development of Provenge is awarded the Nobel Prize in Medicine.

    Be well.

    Ted

    *The Asentar trial eventually was stopped because the drug was killing patients. The $440 million deal between Novacea and SP was terminated.
    Sep 24 04:28 PM | 1 Like Like |Link to Comment
  • Dendreon Shareholders May Yet Have The Last Laugh [View article]
    No argument with anything you've said. Eight (8) treatments of Zytiga, is I believe, the minimum, based on what I have read. And I would welcome reader input on this and on the costs to treat the side effects from the use of steroids and Taxotere with JNJ's treatment. To that end, I again refer readers to David Miller's piece that I referenced in the original article above for a cost comparison of chemo vs. immunotherapy in the treatment of PCa.

    http://bit.ly/mPGhxP

    Finally, DNDN management has much to prove, indeed, when it comes to moving the company aggressively into operations. In that regard, I think everything that can be said about management's failure to control the Street's expectations has been said. Now, we need to wait and see what results the company's plan will yield.

    Take care.

    Ted
    Sep 24 10:41 AM | Likes Like |Link to Comment
  • Dendreon Shareholders May Yet Have The Last Laugh [View article]
    I think it will prove a winner.

    Ted
    Sep 23 11:41 AM | Likes Like |Link to Comment
COMMENTS STATS
1,894 Comments
1,409 Likes