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Theodore Cohen

 
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  • 'Beat Up' Biotechs To Buy: Part 2 [View article]
    Interesting article. Thanks!

    Re reimbursement for Provenge, it's my understanding that with the publication by CMS of the Q-code on August 3, 2011, which provided uniform guidance to all Medicare districts for the payment of Provenge claims, reimbursement sped up almost immediately. On a recent CC, Dr. Gold indicated one provider had been reimbursed within two weeks, with most receiving their money within 30 days.

    You are correct that physician and patient education is key, something the company clearly is focusing on now, more than ever.
    Sep 22 10:32 AM | Likes Like |Link to Comment
  • Adjuvants May Hold Key To Unlocking Cancer Immunotherapy Revolution [View article]
    No, I'm holding.

    And I would not attempt to catch a falling knife. Wait for a bottom, a reasonable bounce, and a test of the bottom (a W formation, with the second low slightly higher than the bottom and the test coming on lower volume) before taking a position or adding to an existing position.

    Go to this site and look at the Daily and Weekly charts:

    http://bit.ly/duZ1er

    Enter VICL as the symbol.

    On the Daily chart, the stock is oversold. It can stay oversold for quite some time. This chart really doesn’t tell us much except the stock broke down technically. We knew that just by the way it was behaving.

    Look at the weekly chart. The stock is approaching an oversold condition. If you draw a line from the low in the fall of 2009 through the low in the late winter of 2010-2011, it suggests a bottom at $2, where the stock would be a BUY.

    This is not the time to stick your neck out. Watch and wait.
    Nothing has changed, fundamentally, with this company. It’s the same company it was yesterday, last week, last month, four months ago…except we are closer to locking the AV-7 database, have more patents, and moving ahead with the pipeline, which includes their HPV2 vaccine.

    These times are painful. I've been through them many times over the years. It's simply a part of investing, albeit unpleasant (in the extreme).

    Ted
    Sep 21 09:21 PM | 1 Like Like |Link to Comment
  • Adjuvants May Hold Key To Unlocking Cancer Immunotherapy Revolution [View article]
    Technically, it's $3. At Schwab (and, I'm sure, other brokers), the stock now has a 100% margin requirement. The stock lost it's loan value when it crossed $3.

    Ted
    Sep 21 07:35 PM | Likes Like |Link to Comment
  • Adjuvants May Hold Key To Unlocking Cancer Immunotherapy Revolution [View article]
    You might want to tune in to the next presentation by Mr. Samant. Perhaps the question of recent price movement will be raised.

    Ted

    JMP Securities Healthcare Conference (New York, September 27 – 28) on Tuesday, September 27, at 11:00 a.m. EDT.

    Webcasts of Mr. Samant's presentations at the Stifel Nicolaus Conference and the JMP Securities Conference will be available live and archived through the Events & Presentations page in the Investors section of the Vical website at http://www.vical.com.
    Sep 21 06:50 PM | Likes Like |Link to Comment
  • Adjuvants May Hold Key To Unlocking Cancer Immunotherapy Revolution [View article]
    From IR:
    “No developments at the company that would account for the recent selloff. Strictly market-driven.”

    I also heard that margin was raised to 100%, and margin calls were the primary motivator.

    Nothing makes much sense these days.

    Ted
    Sep 21 06:45 PM | Likes Like |Link to Comment
  • Neuvenge: Dendreon's Treatment For Bladder Cancer [View article]
    All good comments. Money is always an issue, expecially when it takes so long to run trials. DNDN went through something $1 billion bringing Provenge to market.

    As you know, one of the problems that DNDN faces--and it's easily solved--is determining who insurance will cover. For this, a bone scan probably is the best determinent. Which goes too the heart of your last point: care providers need to follow patients closely so that you can determine at the earliest possible time when they are eligible to receive Provenge. Once the disease goes metastatic, things start to go bad quickly, and the window for immunotherapeautic treatment closes fast. The patient may expire, but the lawsuits linger on!

    Be well.

    Ted
    Sep 21 11:49 AM | Likes Like |Link to Comment
  • Adjuvants May Hold Key To Unlocking Cancer Immunotherapy Revolution [View article]
    Excellent article. The references are much appreciated. Ted
    Sep 20 05:44 PM | Likes Like |Link to Comment
  • Neuvenge: Dendreon's Treatment For Bladder Cancer [View article]
    Comments from a friend of mine who follows the science closely (I think you will find these comments helpful):

    There really aren't much new news in these abstracts. The main thing is that they continue to support the picture that Provenge will work for nearly all patients, except perhaps those at their end already.

    1. Pain is a sign of tumor formation. So, delay of pain is delay of tumor formation. The first abstract on TTDRP provides some evidence that Provenge did prevent tumor formation once it gets the immune system going after about 6 months. The longer survival time of treated patients could be explained by this.

    2. The OpenACT abstract continues to confirm that Provenge elicits both cell-mediated and humoral immunity against cells carrying the PAP antigen. Acting against such cells is the putative mechanism of action of Provenge. So this is another piece of evidence that Provenge works. What they need to do is to perform regression analysis that directly connect the upregulation of the various immunity signals and the delay of pain or survival. This is kind of like the analysis they did with CD54 but at a patient-by-patient level instead of quantizing them.

    3. The last abstract basically just says what we all know already that it does not really matter what other treatments have been applied, including Taxotere, Provenge still helps patients. What this also means is that certain patients who miss Provenge early because of an aggressive disease could be treated with Taxotere to arrest the disease so that they could get back into the minimal pain state. Then, they can be treated with Provenge again. The marketing people for DNDN will have to work closely with oncologists to make sure that they know this so that these patients can be properly treated. Their life depends on it.
    Sep 20 12:20 PM | Likes Like |Link to Comment
  • Neuvenge: Dendreon's Treatment For Bladder Cancer [View article]
    McB....You may find this abstract for the program in Stockholm of interest.

    http://bit.ly/qZOFHn
    #7002
    Time to Disease-related Pain After Sipuleucel-T in Asymptomatic Patients With Metastatic Castrate Resistant Prostate Cancer (mCRPC) - Results From 3 Randomized Phase III Trials
    E.J. Small1, C.S. Higano2, P.W. Kantoff3, J.B. Whitmore4, M.W. Frohlich5, D.P. Petrylak6
    1UCSF Comprehensive Cancer Center, Urologic Oncology, San Francisco CA, USA ; 2University of Washington, Medical Oncology, Seattle, USA ; 3Dana-Farber Cancer Institute, Division of Solid Tumor Oncology, Boston, USA ; 4Dendreon Corporation, Biometrics, Seattle, USA ; 5Dendreon Corporation, Clinical Affairs, Seattle, USA ; 6Columbia University Medical Center, Division of Hematology Oncology, New York, USA
    Abstract
    Background: Sipuleucel-T, an FDA-approved therapy for men with asymptomatic or minimally symptomatic mCRPC, has a demonstrated survival benefit. In addition to survival data, 3 completed Phase III, randomized, controlled trials sponsored by Dendreon Corp. also collected data on time to disease-related pain (TDRP).

    Materials and Methods: Studies D9901 (NCT00005947) and D9902A (NCT01133704) enrolled only asymptomatic pts; TDRP was a secondary endpoint. Pain status was collected until disease-related pain or 4 weeks following disease progression, whichever occurred first. The IMPACT study (NCT00065442) originally enrolled only asymptomatic pts with a co-primary endpoint of TDRP; it was later amended to include minimally symptomatic pts and to remove the TDRP endpoint. Pts were treated with 3 infusions of sipuleucel-T or control at approximately 2-week intervals, and were then followed for safety and clinical endpoints. Pain status for pts enrolled prior to the amendment was collected until disease-related pain was observed. TDRP was assessed in all studies by pain logs and adjudicated by blinded independent reviewers. TDRP was analyzed using the Kaplan¨CMeier (KM) method and log rank test; hazard ratio (HR) was derived from an unadjusted Cox regression model. Analyses were based on all randomized pts on D9901 (n=127) and D9902A (n=98), and on IMPACT pts randomized prior to the amendment (n=203).

    Results: TDRP results were: D9901 HR=0.68, D9902A HR=1.39, and IMPACT HR=0.80. Integrated results were HR=0.84 ([95%CI: 0.64, 1.12]; P=0.24). Separation in the KM curves was seen at approximately 6 months. Median TDRP was 5.6 vs 5.3 months. At 12 months 39.3% of sipuleucel-T vs 18.9% of control pts were estimated to be pain-free. Significant independent baseline predictors of earlier TDRP were higher PSA, higher alkaline phosphatase, lower age, bisphosphonate use, and prior radiation therapy. When adjusted for these clinical factors, the adjusted treatment HR=0.80 ([95%CI: 0.60, 1.08]; P=0.14).

    Conclusions: The trend towards a delay in TDRP beginning 6 months after randomization is consistent with the potentially delayed anti-tumour effect of immunotherapy. These data provide support for a potential effect of sipuleucel-T on a clinically relevant endpoint proximal to the demonstrated benefit in overall survival. Lack of statistical significance could be due to limited sample size, high rate of censoring, or delayed treatment effect.

    There are two other abstracts on Provenge, as well.

    http://bit.ly/qZOFHn
    #7011

    http://bit.ly/qZOFHn

    #7012

    Ted
    Sep 20 07:38 AM | Likes Like |Link to Comment
  • Neuvenge: Dendreon's Treatment For Bladder Cancer [View article]
    Thanks for the added 'color.' It's unfortunate that the trials take so long and Neuvenge only is in Phase 2. But clearly, this is something we want to watch closely. As always, you comments are very much appreciated by all who read SA.

    Be well.

    Ted
    Sep 18 09:54 AM | Likes Like |Link to Comment
  • Vical: Making Progress In The Area Of HSV-2 Vaccines [View article]
    I'm certainly looking forward to an announcement that they have locked the AV-7 database. As well, I'd like to see their HSV-2 vaccine advance. Eventually, I believe this company will be taken over by one of its partners.

    Ted
    Sep 17 10:05 PM | Likes Like |Link to Comment
  • Neuvenge: Dendreon's Treatment For Bladder Cancer [View article]
    I don't know. What medications each individual patient is on, remains on, or is placed on is, I would almost be certain, unique to his condition. Perhaps one of the oncologists or urologists prescribing Provenge can answer your question.

    Ted
    Sep 17 08:02 PM | Likes Like |Link to Comment
  • Neuvenge: Dendreon's Treatment For Bladder Cancer [View article]
    They delivered well over 700 doses in August, and September dosing was well ahead of August, at last report. They are no where near saturating the capabilities of their three facilities.
    Sep 16 05:55 PM | Likes Like |Link to Comment
  • Dendreon and Fuzzy Journalism: Wherein lies the truth? [View instapost]
    For PCa...I have no idea. And I'm not sure how one would go about obtaining that number, given that it's used both on- and off-label to treat patients of this indication. I wish I could give you a better answer.

    That said, look at these data:
    Estimated new cases and deaths from prostate cancer in the United States in 2011:
    New cases: 240,890
    Deaths: 33,720
    www.cancer.gov/cancert...

    One would have to believe that the number treated with Taxotere each year is in the tens of thousands.

    I wish I could give you a better estimate.

    Ted

    Sep 16 11:23 AM | Likes Like |Link to Comment
  • Neuvenge: Dendreon's Treatment For Bladder Cancer [View article]
    Thank you. That's the intent. As you know from your investigations and writings on Seeking Alpha, the data are out there, but sometimes, are not easy to bring together and make understandable. Ted
    Sep 11 09:05 AM | Likes Like |Link to Comment
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