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McBride

 
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  • High Risk Trading With Dendreon [View article]
    Bogus argument in regards to cost being a detractor:

    "On an average, each patient will have to shell out about $93,000 per therapy. This amount is quite expensive."


    I'd like to see one article about a patient needing to pay for this treatment themselves, as often eluded to in these opinion pieces.

    I reassure you all, the financial risk is not on the patients, it is on the practices burdened with providing information to the insurance companies. The information substantiating the need for Provenge includes lab data, radiographic evidence of boney metastatic disease, ECOG performance scales, failure of antiandrogen therapy by documenting low testosterone levels, proper amounts of white blood cells, etc.

    FYI, Dendreon was able to provide Provenge for a patient in our community who is a farmer and owns his own greenhouse business, but never bought health insurance and was too young for Medicare. He had the apheresis and immunotherapy given gratis, as Dendreon utilized cancer-care funds, and his only cost was office visits and infusion time.

    The attempts to imply that the treatment costs $93,000 to the patient, are absurd. Insurances cover this treatment very well, and the nightmare scenarios of rejections have NOT HAPPENED otherwise doctors would be complaining severely, the company would be reeling, and the middleman medical supply financiers (McKesson, and the likes) would be putting doctors into collections.
    Apr 11 11:41 AM | 3 Likes Like |Link to Comment
  • New Battleground Emerges For Dendreon Bulls And Bears [View article]
    Additionally, in your examples, the PSA is being properly used as a surrogate marker for the progression of your disease. Other clues include your clinical picture (symptoms, hematuria, etc.) and radiographic evidence of progression of disease (bonescans, CT scans, MRIs)
    Apr 11 10:49 AM | Likes Like |Link to Comment
  • New Battleground Emerges For Dendreon Bulls And Bears [View article]
    from Provenge's healcare professional website:

    PSA and PROVENGE

    Changes in PSA responses may not reflect treatment response to PROVENGE.1

    As opposed to cytotoxic therapies, which have their greatest effects soon after initiation of therapy, immunotherapies such as PROVENGE require time to generate an immune response, and evidence of activity may be delayed.2,3
    1.Data on file.
    2.Madan RA et al. Oncologist. 2010;15:969-975.

    http://bit.ly/ZP6kqh

    In the field, we are tracking PSA, but also looking at radiographic evidence that Provenge may be working. That is, we are looking to see if new metastatic disease is found on bonescans. Conversely, we are looking to see if NO further metastatic disease is seen on bonescan, while often time the PSA is rising.

    Your examples otherwise are cases where PSA is being tracked to guage the efficacy of antiandrogen therapy, which commonly drops the PSA sharply due to the deprivation of androgens and prostate cancer cell deactivation. If prostate cancer cells are being destroyed/phagocytosed by the immune system, while the target antigen for Provenge is not even PSA, rather, it is PAP (prostatic acid phosphatase)
    Apr 11 10:47 AM | Likes Like |Link to Comment
  • Dendreon's Provenge Ads: Are They Working? [View article]
    Come on, "DR"?! Example, cardiologists send their patients for treatments at electrophysiologists, invasive radiograpy at outpatient clinics for angiography, etc.

    If Physicians, an oncologist or urologist were employed per diem or with contract at the Dendreon outpatient clinic, as well as Red Cross certified phlebotomists and apheresis techs, possibly even a general or vascular surgeon available to put in central venous lines in an outpatient surgical clinic within the facility...all of this very billable so the incentive to work there would be real.

    CEO Johnson isn't nearly as stupid as Mr. $93,000 x amount of metastatic cases per year = my lofty stupid sales projection that got killed along with the stock price Dr. Gold.

    This model could emerge within the Dendreon management if they realize the potential. As many new sites as they open, I wonder how many have become relative inactive.
    Apr 10 10:07 AM | 1 Like Like |Link to Comment
  • New Battleground Emerges For Dendreon Bulls And Bears [View article]
    No. PSA can not be used to determine of Provenge is working or not.
    Apr 9 01:39 PM | Likes Like |Link to Comment
  • New Battleground Emerges For Dendreon Bulls And Bears [View article]
    There's a lot to talk about with your clinicians about antidepressants, Viagra like drugs, and Provenge. They skimmed the surface and the ad was useful not as an education tool, but will be moreso a driver of curiousity. Whether that turns into treatments is still subject to the narrow funnel through which patients need to pass- I guarantee patients asking about Provenge when they are perfectly treated with low stable PSAs will not impact Rx rates, just make Urologists increase their talk time by 30 seconds. It may however, hold urologist's feet to the fire to recognize patient interest, make sure the patient is being treated well enough (stable low PSA, not rising, recent bone scan if the PSA is rising)

    I as a clinician think this will do little to the prescription rate. Other ads may do better to specifically detail a case, like a man who has been on Lupron-like meds, and his PSA is still rising. Anxiety provoking for the majority of patients, and give an example pictorially of a man with a bad bonescan, then show the urologist explaining that he can either move to other therapies with singificant side effects or move on to Provenge with the relatively few side effects.

    In other words, a more realistic commercial, clinically more relevant, and less about washing dishes.
    Apr 9 10:30 AM | Likes Like |Link to Comment
  • New Battleground Emerges For Dendreon Bulls And Bears [View article]
    I would not consider Provenge a treatment of last resort. In fact, no well-trained urologist would. In combination with other therapies, immunotherapy and Provenge will prove to be synergistic and may be used earlier in the disease state when tumor cell burden is lower. Consider the current FDA approval an acid-test, with the company's greatly inflated unrealistic goals (Dr. Gold) trarnishing its image early on.

    Great points, Lawrence, and if you look at clinicaltrials.gov, there are clinical trial ongiong and enrolling in the realms that you are mentioning.

    I also agree with you that a biomarker needs to be developed SOON- to prove that it is working during therapy.
    Apr 9 10:25 AM | Likes Like |Link to Comment
  • Dendreon's Provenge Ads: Are They Working? [View article]
    I think the material on their website is fantastic. I am not sure if that is regulated by the FDA or not, but it certainly is more substantial than the Viagra-like commericial that shows a guy flirting with his wife while doing dishes. I will continue the cynical streak on this topic!! En guarde!!
    Apr 5 02:32 PM | Likes Like |Link to Comment
  • Dendreon's Provenge Ads: Are They Working? [View article]
    That is where the ad failed, to deliver a short scientific message in video form, that this is so revolutionary because...and contrasting against the side effects of chemotherapy (as Provenge before chemo is a major decision point for patients)
    Apr 5 01:12 PM | Likes Like |Link to Comment
  • Dendreon's Provenge Ads: Are They Working? [View article]
    I still wonder what would happen if Dendreon opened a few apheresis/infusion centers of their own, which would enable doctors to simply write a Rx for the treatment, what would happen to the numbers...if I were hired by Dendreon and had any sort of budget involving the last TV ad campaign vs. centers, I would have chosen the latter. As the NON-UROLOGIST/NON-ONCO... CEO I would care less about how much money I take out of their pockets. Why Johnson can't see this, is beyond me.
    Apr 4 11:39 AM | Likes Like |Link to Comment
  • Dendreon's Provenge Ads: Are They Working? [View article]
    I think the Ad stinks. It does nothing to generate focused attention. It is like an old Viagra commercial and spits out all the negatives. The ad interest does nothing to mention the product where it would be a best fit for an advanced prostate cancer patient. Comparisons to traditional chemotherapy could have been made. It's just mentioned to be an option but HOW MUCH of a better option? Personally I think the company should be reserving more money to detect an assay, or a combination of labs, or whatever...to tell us clinicians that this stuff is working objectively, not subjectively observing that it must be working because the patient is still coming to the office. I guess I'm fed up.
    Apr 3 02:29 PM | Likes Like |Link to Comment
  • Dendreon's Provenge Ads: Are They Working? [View article]
    Dendreon Corp. (NASDAQ:http://bit.ly/ySVxZX): The company’s recently initiated TV ads for Provenge is viewed by Leering as increasing patient interest. The firm has stated that according to Google Trends, web searches for the company’s prostate cancer drug saw a rise to their highest levels in two years. However, Leerink has stated that the sales impact from the ads continue to be unclear, and it reiterates its Market Perform rating on the stock.

    Leerink Swann made this call, or Ted? Both? http://bit.ly/12hAGFq
    Apr 3 02:27 PM | Likes Like |Link to Comment
  • The Dendreon Bear Raid Of 2009: Chasing The Perpetrators [View article]
    HAHAHAHA one guy in a Las Vegas apartment. The rest of it I won't laugh at because it's not funny, it's just wrong.

    So if the baseline of this stock was changed during this time Ted mentions, would DNDN not POSSIBLY be operating at different stock prices today, Dr. Wheaton?

    Could there possibly not be reimbursement to investors who held at that date, or at least, lessons learned and SEC heads rolling, because of this important date in DNDN trading? He's not rehashing ancient news, and if he is, can you post a link to likewise information?

    Competition is poised to take away the gains? When all clinical data points towards sequenced therapy? No pipeline? Dude what are you smoking?

    At least you're funny, Dr.
    Mar 5 03:42 PM | 2 Likes Like |Link to Comment
  • A Comprehensive Look At Immunotherapy - Part 2 [View article]
    Thanks, Brian.
    Well done, Brian. Focused and parallel to the title.

    With regards to prostate cancer, I like this article as well, titled "The Growing Understanding of the Potential Influence of Immunotherapy in Prostate Cancer"

    http://bit.ly/VAs6Sz

    Interviews are great and yours was well focused. I also invite your readers to entertain a broader view of immunotherapy with this article.
    Mar 5 12:17 PM | Likes Like |Link to Comment
  • Dendreon: Startling Results Sequencing Provenge After Medivation's Xtandi [View article]
    I apologize, this is still a recruiting study for immune response, they are still looking at re-infusions. Initial studies have verified CD54 upregulation, and are completed.

    The clinical trial study design for the re-treatment trials are here: http://1.usa.gov/XKXGvk

    The endpoints there will be:

    Primary Outcome Measures: •To evaluate the immune response generated by sipuleucel-T [ Time Frame: Change in immune response from Baseline through Month 12 ] [ Designated as safety issue: No ]
    Antigen-specific T cell responses will be assessed by mean of a proliferation assay and an interferon-gamma enzyme-linked immunospot (ELISPOT) assay. Antigen-specific humoral immune responses will be measured by means of an enzyme-linked immunosorbent assay (ELISA)


    Secondary Outcome Measures: •To evaluate the safety of sipuleucel-T [ Time Frame: Baseline to study completion ] [ Designated as safety issue: Yes ]
    Safety will be assessed by summarizing adverse events, laboratory evaluations, vital signs, and physical examination findings.


    •To explore the correlation between sipuleucel-T immune response and overall survival. [ Time Frame: Baseline to study completion ] [ Designated as safety issue: No ]
    Mar 5 12:07 PM | 1 Like Like |Link to Comment
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