Seeking Alpha
View as an RSS Feed

McBride  

View McBride's Comments BY TICKER:
Latest  |  Highest rated
  • Is Dendreon Done After Q1 Train Wreck? [View article]
    How is this a train wreck when the company itself predicted lower sales in Q12013? Sales catalysts continue to be combination therapy, European approval, and the fact that immunotherapy, and specifically Provenge, is not going away. The idea of BP buying the patented process of autologous active immunocelular therapy and shelving it is absurd. The company will exist to fight this and become profitable. BUY BUY BUY. Long.
    May 10, 2013. 10:24 AM | 1 Like Like |Link to Comment
  • Bracing For Dendreon Q1 2013 Earnings - All Eyes On Provenge [View article]
    Blew? Care to break that down?
    May 9, 2013. 01:30 PM | Likes Like |Link to Comment
  • Bracing For Dendreon Q1 2013 Earnings - All Eyes On Provenge [View article]
    A good long investment goes on sale...with great upside. Long!
    Ted Cohen's article reflecting on the study with Provenge + Xtandi is what shows greatest promise from my clinical standpoint. A synergy with those two treatments will keep me investing, as well as the European market opening up.
    May 9, 2013. 12:51 PM | Likes Like |Link to Comment
  • Bracing For Dendreon Q1 2013 Earnings - All Eyes On Provenge [View article]
    And just to follow up, I looked at the entire list of 25 ongoing, completed and recruiting studies for Provenge at clinicaltrials.gov. I do not see one for Provenge therapy during active surveillance- but I would still hold on to the $93,000 and wait a few years. I would write to Dendreon and to the major medical centers asking them to please study this population, in good science. However, NCCN guidelines would advise that I seek other treatments until the current FDA indications are met. Good study results using Sip-T in non-metastatic low grade, low volume T1 disease are going to be 3-5 years off from even starting, or more.
    May 8, 2013. 04:58 PM | Likes Like |Link to Comment
  • Bracing For Dendreon Q1 2013 Earnings - All Eyes On Provenge [View article]
    Ken, only about 40% of new diagnoses of prostate cancer typically fall into the active surveillance category. These are the "very low risk" prostate cancer with <20 years life expectancy, and and "low risk" prostate cancers with life expectancy <10 years. This is based on risk recurrence as outlined in PROS-2.

    This is an arena that Provenge is currently NOT indicated for, and studies regarding patients on Active Surveillance, non-metastatic prostate cancer treating with androgen deprivation before or after Sip-T/Provenge are ongoing (there are many treatments and radiographic studies that may include the Active Surveillance space to gain popularity and sales there) are available at http://1.usa.gov/HGVQAF

    This would be a study of interest to you in that regard http://1.usa.gov/10H3yns
    And there is also a study for men with hormone sensitive disease
    http://1.usa.gov/16hQoWq

    If I became a patient who qualified for Active Surveillance, I would enroll in one of them and keep the $93,000 in my pocket for a few years while the data emerges and insurance coverage settles in. Could take 3-5 in my estimation, at the soonest.

    Don't shoot me for being a conservative DNDN investor, I've made a habit of this, mocking Dr. Gold for his metastatic cases per year x $93,000 = one really bad earnings forecast that needed to be pulled. Assuming 100% market penetration was a poor-quality prediction.

    Predicting that the Provenge market gets 10 times bigger based on anecdotal evidence, leading to off label usage and patients PAYING $93,000 for these treatments, is a poor-quality prediction.

    I am inspired, however, that if you had prostate cancer, very low risk or low risk, that you would buy the $93,000 treatment. You must have a firm grip on some post-treatment data that makes you feel this would be a good investment if you were in that situation.

    I just hope, that in the reality of things, Dendreon is used when it is most efficacious and appropriate, which is the way good science would let it exist.

    Long. Very long. Is the stock going on sale tomorrow?
    May 8, 2013. 04:40 PM | Likes Like |Link to Comment
  • Bracing For Dendreon Q1 2013 Earnings - All Eyes On Provenge [View article]
    I am in attendance at the American Urological Association's annual meeting in San Diego. I can tell you one thing, Brian... Dendreon is not going away, nor is Provenge immunotherapy.

    The most important take-home message I have for non-clinicians investing in DNDN- stay long, but buy low (late 2013 may be the latest lower points, given pending European approval)... initial sales history on this treatment will of course affect the stock price negatively, while the science will lift it up long term. Don't be too short-sighted.

    Specifically, combinations studies with Xtandi-Provenge, Zytiga-Provenge, and later on, immunotherapies that compliment Provenge (which triggers the immune response) will essentially take off the "brakes" that the cancer cells put on the immune response- they try to fool the immune system into thinking the cell is normal, and the future immunotherapies will take this capacity to "fool" away from the cancer cells- making Provenge even more effective.

    Provenge will continually be pushed to earlier in the metastatic disease state- certainly before even the newest chemotherapies. The antiandrogen market is completely satisfying, with Xtandi the newer agent and Zytiga the older. Both with share market in antiandrogens, a newer antiandrogen degarelix acetate (tradename Firmagon) will dilute the market share progressively in that market.

    What I can also tell you, again in support of DNDN, is that its uniqueness in the metastitic prostate cancer space is very evident- and its cost is actually quite irrelevant- as there exists the necessity of sustaining a patient on older LHRH agonists, or newer antiandrogens like Xtandi or Zytiga, then moving them to chemotherapy.

    The experts are also very confident that alpharadin (radium-223) will be huge in boney metastatic disease, specifically for the boney metastatic disease.

    I would also invest in the makers of Prolia and Xgeva, Amgen, as they continue to progressively outcompete against Zometa in the antiandrogen-induced osteoporosis and prevential of skeletal events arenas.

    As Brian, you claim to hold no positions in the involved stock(s) namely DNDN, I implore you to take a closer look at your investment in metastatic prostate cancer therapy based on these clinical trends. Your short interest in this stock has become more evident over time. Presuming since you declare no shared owned, you are naked shorting on DNDN?

    If you wish, the AUA sells their webcasts if you don't wish to take my word for it.
    May 8, 2013. 12:28 PM | 4 Likes Like |Link to Comment
  • A Look At The Prostate Cancer Treatment Market [View article]
    Agreed that pre-chemo patients may be healthier, and would travel better, but, with the current USA FDA indication for pre-chemo, is this a real worry?

    I would think the EU indication would be for pre-chemo as well.
    Apr 24, 2013. 01:20 PM | Likes Like |Link to Comment
  • A Look At The Prostate Cancer Treatment Market [View article]
    This would be an opportune time for DNDN to change the delivery model for Provenge. If I were the CEO/board I would recommend regional centers, perhaps one or two in each country where the patient could be sent for apheresis and treatment.

    Let it go on record this is the first time I agree almost fully with Dr. Wheaton. Fortunately for Dendreon, and despite the "competition" Dr. Wheaton and others have time and again tried to portray as the ultimate Provenge killers (ignoring again the synergy and sequencing being studied STILL) Dendreon has to be working on a more flexible business model to be rolled out to each European country that comes on board.

    The expenses of setting up indiviual accounts instead of regional centers may prove too costly. Even supplying the financial support for transportation and lodging for 3 treatments might be a more cost effective solution than doing all the STUFF Dr. Wheaton mentions above.

    Basically, I'm hoping Dendreon has the intellectual assets and personell required to pull off this shift into Europe.

    But that mentioned, an approval in Europe will do NOTHING to hamper sales in the United States. You'll see how aggressively Europeans (based on a need for cost-efficiency) study the post-Provenge patient instead of relying on faith and repeat bonescan xrays, and how quickly they develop bloodwork assays that correlate with increased survival times.

    Not only are they likely tapping into the European patient market, but a well led Dendreon should be looking to tap into into the European biopharma salesperson and biological scientist market to employ leading edge people over in Europe.

    They have learned so many strong lessons and the upside is huge.
    Apr 22, 2013. 02:05 PM | Likes Like |Link to Comment
  • A Look At The Prostate Cancer Treatment Market [View article]
    They won't reduce the cost until they reduce the COGS. The patient is not influenced by the cost of the treatment, as it is paid for by insurances. Additionally, if you look at the static one time cost of Provenge vs. ongoing therapy with Zytiga, the cost overall for Zytiga is higher within the expected life extensions.

    + EMA decision will be sequential good news based on individual countries coming on board, so one EMA decision will boost the stock price while individual countries and DNDN additional sales data from Europe will influence the stock.

    The possible partnership you speak of would more likely be JNJ buying DNDN and paying a premium over it's current value based on buying patented technology. Anyone who can predict the price per share on a takeover bid based on + EMA deicsion and increasing sales during reduced COGS is a good boy/girl.
    Apr 18, 2013. 11:54 AM | Likes Like |Link to Comment
  • New Battleground Emerges For Dendreon Bulls And Bears [View article]
    I called Dr. Gold out in my first article ever, which focused more on the limitations on the number of Provenge treatments (logistics) and, DNDN actually put their paperwork online like I predicted.

    "Before you listen to Dendreon's estimate that 30,000 to 36,000 patients per year could qualify for this treatment, please remember that would be around 100% market penetration, as only about 29,000 to 36,000 die from metastatic prostate cancer each year."

    Source: http://seekingalpha.co...
    Apr 17, 2013. 09:53 AM | Likes Like |Link to Comment
  • New Battleground Emerges For Dendreon Bulls And Bears [View article]
    I would argue that the yield (the amount of Provenge treatments started) will be higher in the urology offices than in the oncology offices, based on the fact that oncologists will be more apt to write for Taxotere, then Xtandi. Even Zytiga, being a pill that generates NO income for the oncologist besides the office visit to talk about it, is probably more likley a recommendation to the patient failing LHRH agonists (and other antiandrogens)
    Apr 17, 2013. 09:48 AM | Likes Like |Link to Comment
  • High Risk Trading With Dendreon [View article]
    No deaths? Elaborate, please. I've had a patient die 6 months after his Provenge therapy, but it was before Zytiga and Xtandi were widely used. Do you mean no death from complications of the treatment?
    Apr 17, 2013. 09:44 AM | 1 Like Like |Link to Comment
  • High Risk Trading With Dendreon [View article]
    Let me also add, the use of Prednisone 10mg daily is not what most clinicians are doing, they are doing 20mg daily. Patients are exposed to HUGE side effects with prednisone therapy. Additionally, patients are advised to take prednisone (a glucocorticoid). What happens when the prednisone is abruptly stopped? You need to watch the patient's mineralocorticoids (involved in regulating electrolytes in the blood). This treatment (Zytiga) puts patients at risk of mineralcorticoid excess which has TONS of cardiac side effects!!!

    Don't just take my word for it http://bit.ly/wEIP6X

    "Hypertension, Hypokalemia and Fluid Retention Due to Mineralocorticoid Excess - Use with caution in patients with a history of cardiovascular disease or with medical conditions that might be compromised by increases in blood pressure, hypokalemia, or fluid retention. ZYTIGA® may cause hypertension, hypokalemia, and fluid retention as a consequence of increased mineralocorticoid levels resulting from CYP17 inhibition. Safety has not been established in patients with LVEF <50% or New York Heart Association (NYHA) Class III or IV heart failure (in study 1) or NYHA Class II to IV heart failure (in study 2) because these patients were excluded from these randomized clinical trials. Control hypertension and correct hypokalemia before and during treatment. Monitor blood pressure, serum potassium, and symptoms of fluid retention at least monthly.

    Adrenocortical Insufficiency (AI) - AI was reported in patients receiving ZYTIGA® in combination with prednisone, after an interruption of daily steroids and/or with concurrent infection or stress. Use caution and monitor for symptoms and signs of AI if prednisone is stopped or withdrawn, if prednisone dose is reduced, or if the patient experiences unusual stress. Symptoms and signs of AI may be masked by adverse reactions associated with mineralocorticoid excess seen in patients treated with ZYTIGA®. Perform appropriate tests, if indicated, to confirm AI. Increased dosages of corticosteroids may be used before, during, and after stressful situations."

    To make things worse, there is a national shortage of endocrinologists. Again, don't just take my word on that http://bit.ly/10TePCW


    The manufacturers of Zytiga and its (lack of better) recommendations will wind up in court one day due to patients running into adrenal crisis.
    Mark my words: someday Zytiga will be on the 1-800-BAD-DRUG ads and JNJ will be paying for class action suits and settlements.
    Apr 13, 2013. 02:49 PM | 1 Like Like |Link to Comment
  • High Risk Trading With Dendreon [View article]
    @ Larry, this was the jist of my response prior, that PSA is not a biomarker that can be used exclusively to gauge the efficacy of the treatment.
    However, I will tell you this- as we have no other well studied guidelines (lab assays correlating to increased survival times) that are time-tested (it may in fact turn out to be a GROUP of tests with absolute values OR A COMPLEX combination or ratios of assays) we are currently using a treatment (Provenge) that has NO IMMEDIATE VERIFIABLE GAUGE OF EFFICACY. That is, we can't say PSA going down is proof it is working.

    We can continue to use PSA to verify that the disease is spreading.
    Currently post-Provenge, if the PSA is continuing to rapidly rise, then the patient may be sent for additional therapy. Zytiga can be given pre-chemo.

    If the patient wishes to have Xtandi:
    A classic example at this point (April 2013), may be a dose (yes, just a dose of Taxotere/chemo, then rising PSA or intolerance in bad cases- or a medical oncologist who tells the patient he is doing just FINE on chemo if the PSA stays down, that is a successful and tolerated cycle of Taxotere), then on to Xtandi.
    Apr 13, 2013. 02:15 PM | Likes Like |Link to Comment
  • High Risk Trading With Dendreon [View article]
    You could get the treatment from a study facility in that setting, I would hope. I would consult with clinicaltrials.gov and continue to watch for enrolling clinical trials.

    Larry, here's a link you may want to really read hardcore.

    http://1.usa.gov/12WMDEO
    Apr 13, 2013. 02:04 PM | Likes Like |Link to Comment
COMMENTS STATS
410 Comments
251 Likes