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  • Vical's Allovectin-7: Are The Phase 3 Trial Results Hiding In Plain Sight? [View article]
    You're welcome. Thanks for stopping by.

    Ted
    Oct 2 11:26 AM | Likes Like |Link to Comment
  • Vical's Allovectin-7: Are The Phase 3 Trial Results Hiding In Plain Sight? [View article]
    I just read this interesting exchange on the Yahoo! MB (thanks to Moohshooter) that this MB might find interesting.

    Ted

    http://bit.ly/qHByNS;bn=19346&tid=...
    Oct 2 10:22 AM | Likes Like |Link to Comment
  • Vical's Allovectin-7: Are The Phase 3 Trial Results Hiding In Plain Sight? [View article]
    Hi, gebroida. Thanks for stopping by.

    Nothing's engraved in stone in this business. That timeframe seems to be corporate's target (it's been mentioned many times...listen to the recordings on the Vical Web site), and I'm sure they are very anxious to lock the database and see what the data hold. That said, I think we definitely would hear something either in June or July.

    And yes, their HSV-2 work is extremely interesting. It was the subject of a piece I wrote about a month ago.

    http://seekingalpha.co...

    My personal feeling is that sooner or later, one of their partners, upon the success of one of their collaborations, will buy this company in the $8-$10 range. And my gut says this will happen sometime in the next two to three years. And no...that's not engraved in stone. (;>)

    Be well.

    Ted
    Sep 30 09:41 PM | 1 Like Like |Link to Comment
  • Vical's Allovectin-7: Are The Phase 3 Trial Results Hiding In Plain Sight? [View article]
    Hi, Scottaa. And thanks.

    Lots of risk, of course, in any trial. And if you listen to Mr. Samant, he's quite candid as to the various reasons why a trial can be extended in time.

    But yes, the Phase 2 results were encouraging.

    The new BMS drug made it through the FDA by the skin of its teeth. Which shows what Big Pharma can do. Or is it just what BMS can do in CDER/ODAC? (;>)

    Ted
    Sep 30 03:39 PM | Likes Like |Link to Comment
  • 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
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