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Krispy Kreme Doughnuts, Inc. Message Board

neelsen01 113 posts  |  Last Activity: Jul 22, 2015 1:09 PM Member since: Feb 13, 2013
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  • If we make it to Iomab-B approval on our own through share offerings, PPS could be suppressed, but revs will be coming in immediately after FDA approval. At that point, we may not need a partner with $300+M revs coming in the first year.

    Sentiment: Strong Buy

  • Reply to

    ALERT ALERT !!! PUMP AND DUMP calgarycraig

    by ellid Jul 13, 2015 5:40 PM
    neelsen01 neelsen01 Jul 13, 2015 6:30 PM Flag

    A surprise announcement of ph3/partnership my set the floor at $5+. I'm doubling down under $2.20 in stages. May be very hard to get back down under $2.20 going forward imo.

    Sentiment: Strong Buy

  • Thanks very much. We'll be unable to move forward unless this article clearly discusses the subject of paid promotion in ATNM shares. We're looking for more than a disclosure that you have not been paid to write about the stock. We are looking for discussion of the evidence of promotion and how that evidence affects your investment thesis. If you choose to resubmit, please also embed your links. You can do this with the help of the globe tool, next to the underline button on the editing toolbar. Copy the source URL, highlight the text you want linked, click the globe, paste in the URL, and click OK. Finally, the article still reads more as a factual recap than as an investment thesis, so we'd be interested in more focus on why, going forward, this represents and attractive opportunity for investors.

    Sincerely Yours,
    SA Editor Mike Taylor

    Sentiment: Strong Buy

  • "Thanks very much for your submission. We're going to pass on this article because it covers a microcap stock (market cap less than $100 million). ATNM has also recently been subject to a paid promotion. In cases of paid promotion, we ask that authors disclose the promotion within the article and explain how that affects their investment decisionmaking. Additionally, we rigorously apply our biotechnology standards to any article about a microcap. We therefore look for: 1) Quality sourcing -- discussion should be backed up by clear references; 2) Scientific explanation; 3) A look at recent financial performance, cash flows, the balance sheet; 4) A detailed assessment of risk associated with investment. We would consider a reworked version of this article that addressed these items. Thanks very much."

    Sentiment: Strong Buy

  • actual title of article (first draft)

    Sentiment: Strong Buy

  • A BMT offers the only cure for these AML patients. And since Iomab-B offers many of these "worst of the worst" patients their only chance for getting a BMT, the drug itself is curative as ATNM's Dr. Dragan Cicic stated in the KOL May event. www.actiniumpharma.com/investors/actinium-key-opinion-leader/

    Sentiment: Strong Buy

  • So in essence, there is no "ramping up" period for sales at these centers. And here is the main point to remember- this number of BMT centers(30) represent a majority of the BMT market in the US. Incredibly, because of the concentration of this market, Iomab could actually dominate this segment of BMT from day 1 of FDA approval. In the latest KOL event held in May of this year, CEO Dr. Kaushik Dave of ATNM disclosed in the Q&A session that all gating items(for phase 3) were complete except for putting data down on paper. He also pointed out that the company would "take our time" completing this task and subsequently submit an IND to begin the trial. While investors may frown on this, I think it's prudent for the company to be cautious and not make mistakes that could echo Bexxar's errors. On the reimbursement issue, Dr. Turck points out that 20% of the participating hospitals are PPS exempt. And according to Dr. Dave, the company will be collecting data during the trial to prove the economic advantage Iomab has over chemotherapy. Iomab is estimated to be priced at $85,000 while chemotherapy costs between $50-200K for this indication. In addition, with chemotherapy, the patient experiences a longer hospital stay which can increase total costs.

    In summary, Iomab-B offers the patient a faster pathway to BMT with less side effects than chemotherapy. The company has made an astute decision by consulting Dr. Turck to help ensure the commercial viability of Iomab-B. In contrast to Bexxar, Iomab-B should have a much easier transition from the clinical trial stage to commercial stage by virtue of the BMT market concentration and uniqueness of the drug itself. There is no other treatment that comes close to mimicking Iomab-B for its respective market. continued...

    Sentiment: Strong Buy

  • Bexxar was discontinued by GSK after sales dwindled.www.xconomy.com/national/2013/08/26/why-good-drugs-sometimes-fail-in-the-market-the-bexxar-story/

    Now let's take a look at Iomab-B and find out why it is has a better outlook. First, the drug is initially targeting a very specific group of patients that will not require a referral to a specialist pharmacy or physician. The physician simply needs to choose the best drug that can get their patient to a CR for HSCT. The upcoming Iomab-B phase 3 trial will answer the question of which treatment(chemo or Iomab-B) works best, but one thing is already acknowledged and proven- Iomab-B gets a patient to HSCT in much less time (10 days) vs chemotherapy(28-42 days). Also, in the phase 2 trial of Iomab-B for relapsed/refractory AML patients, 27/27 achieved CR. Iomab-B is also believed to at least double the 2 year survival rate compared to any other alternative therapy, so unlike Bexxar(vs Rituxan), Iomab-B is actually already significantly outperforming it's competition(chemo). In both instances(chemo & Iomab), the patient is in the hospital while receiving treatment, so no conflict of interest exists in terms of where the patient is treated.

    Second, Iomab is safe as most adverse events were classified as Grade 2 or less such as infusion site reactions, chills, and nausea. The distribution of Iomab is mostly restricted to bone marrow, the spleen, and liver. Iomab targets CD-45 which is almost universally expressed on AML cells and stem cells and spares red cells and other tissues from damage. This is why these elderly relapsed AML patients can tolerate Iomab better than chemotherapy.

    Third, according to Dr. Roland Turck, the CD-45 mAb clinical sample production will be already scaled for commercial use by the time of launch. The 30 participating centers in the upcoming phase 3 trial will be able to immediately use Iomab commercially on day 1 of FDA approval. continued...

    Sentiment: Strong Buy

  • •Bexxar's troubling past may be causing consternation for investors, analysts, and journalists that may have otherwise taken interest in potential radioimmunotherapy(RIT) drugs.
    •For ATNM's Iomab-B, there are very important differences to Bexxar which I believe makes the case for a successful commercial launch and sustained sales of Iomab-B if FDA approved.
    •ATNM's Iomab-B should be looked on favorably by the FDA because of it's safety and tolerance in over 250 patients. So, no prolonged approval process is expected.

    Let me begin by disclosing I'm a shareholder of Actinium Pharmaceuticals (NYSEMKT:ATNM). My name is Erik Neelsen and an RN by profession.

    I want to start with a brief history of Bexxar. This is a drug that combines tositumomab with iodine 131. Corixa obtained Bexxar from Coulter Pharmaceutical in 2000. GlaxoSmithKline (NYSE:GSK) partnered with Corixa to market and manufacture Bexxar. Bexxar targets the CD20 protein marker for non-Hodgkin's lymphoma in patients who had not responded well to chemo and Rituxan combo. The drug had success as 29% of these patients went into complete remission(NYSE:CR) for a median time period of 25 months. But Bexxar had some adverse effects that may have caused the FDA to wait so long(four years) before approving the drug in 2003 which allowed chemo and Rituxan combo to become the standard of care in that market. Also, in a 2011 study, Bexxar was found to have no statistically significant improvement compared to Rituxan when each was combined with chemo. Here are further events that point to where Bexxar went wrong- once the drug was approved, the patient's oncologist had to refer his/her patient to a nuclear med pharmacy or radiation oncologist that could handle Bexxar, so the patient's oncologist and his/her related infusion center lost money by referring their patient. But there were also problems with supply and reimbursement which didn't help Bexxar's case with these same oncologists. continued...

    Sentiment: Strong Buy

  • Dr. Lazarus suggested Iomab may be able to treat ALL white cell malignancies("across the board"). If Iomab passes this ph3 trial and goes on to do as well for all other indications in blood cancer, chemo may be on its way out for this type of cancer. At $85k/treatment, 300k pts/yr would bring in revs over $25B/yr which could imply a MC of over $250B or $7,000/share.

    Sentiment: Strong Buy

  • So we have to give mgmt. at least some credit for keeping costs low. They've done a great job in working with different hospitals getting Iomab this far, so let's give them some breathing room to get ph3 done right.

    Sentiment: Strong Buy

  • Reply to

    $765 million 1st year revenue...

    by neelsen01 Jun 13, 2015 8:20 AM
    neelsen01 neelsen01 Jun 13, 2015 4:13 PM Flag

    Adults greater than or equal to the age of 60 years old obviously have significant comorbidities or medical problems that younger individuals don’t have. They may have underlying diabetes, high blood pressure, high cholesterol, history of stroke, etc., and they may be on multiple medications to control their medical comorbidities, which may interact or confound the treatment of AML.In addition, patients in the elderly category have a different type of tumor biology than younger patients. AML in the elderly population tends to have a lot of biological features, which are associated with therapy resistance. For example, elderly patients have increased numbers of leukemia cells, which have unfavorable cytogenetics or molecular characteristics, which make it more difficult for them to be cured with standard chemotherapy. Sometimes the leukemia cells in older patients express drug resistant proteins, which also mediate therapy resistance. As well, many older patients have had a pre-existing hematologic disorder, such as MDS, or myeloproliferative disorders, which then make subsequent AML disease much harder to treat. - That's why Iomab is the best resource for these patients.

    Sentiment: Strong Buy

  • Reply to

    $765 million 1st year revenue...

    by neelsen01 Jun 13, 2015 8:20 AM
    neelsen01 neelsen01 Jun 13, 2015 4:06 PM Flag

    I work in the medical field, and I can tell you, if ph 3 turns out as positive as ph 2, MDs and patients alike will want Iomab over chemo. For certain those 11k sickest patients will be given Iomab. The drug will then be moved up to "healthier" AML patients which will happen within weeks after launch. The only limitation to this scenario I see is the availability of the drug itself. Mgnt needs to be ready for the demand of Iomab.

    Sentiment: Strong Buy

  • Acute myeloid leukemia, or AML, is a disease of older adults. The median age of presentation of patients with AML is 69 to 70 years old. In 2014, an estimated 18,860 new cases of AML are expected to be diagnosed in the United States. We also expect there to be a significant mortality associated with this disease and statistics show that about 11,000 patients of these 18,000 will eventually die from this diagnosis.
    Doctors and patients alike will want the safest and most efficacious drug on the market to get them to HSCT in as short a timeframe as possible. Iomab offers the BEST solution for ALL of these patients. And for many, Iomab is the ONLY solution. At $85,000 per treatment x 18,000 patients a year would yield 1st year sales of $1.53B minus 50% for expenses(manf, dist, licensing fee) equals $765M 1st year revenue post FDA approval. Current budget is $15-20M/yr. That would give an EPS of $15/share if we have 50M shares by that time (4yrs). Multiply $15 x 10PE = $150/share min in four years.

    Sentiment: Strong Buy

  • I wonder which ones offer the best advice? lol

    Sentiment: Strong Buy

  • Reply to

    Longs and wannabes

    by terriertrader Jun 6, 2015 9:55 PM
    neelsen01 neelsen01 Jun 11, 2015 9:10 PM Flag

    I'm about to shut down my campaign as well. Nobody wants to listen because they either refuse to see the value or just don't understand the technology. Either way, it's becoming a wasted effort. We may just have to wait until ph 3 finishes and Iomab gets approved. I'll make sure though to retweet all my recommendations on the stock once the rev comes rolling in. I'm sure the same will ignore those tweets as well.

    Sentiment: Strong Buy

  • either they're not interested or do not have an answer to Iomab. My challenge was to anyone to find a reason Iomab would not prove superior to chemo in the upcoming ph 3 trial.

    Sentiment: Strong Buy

  • Think about it- patients cannot take anything BUT chemo in the control group. How can we expect anything different other than a reproduction of the benchmark results? Therefore, Iomab has no choice but to look better. Just based on getting the patient to HSTC in 10days, it is already superior. And guess what happens when Iomab is approved? It will be moved up to healthier patients with AML and other blood cancers because if Iomab can cure infirmed elderly patients, imagine what effect it could have on other patient populations? MDs and patients alike will not settle for any other treatment. The possibilities are remarkable.

    Sentiment: Strong Buy

  • Reply to

    Special thanks to Akiva Felt of Oppenheimer...

    by neelsen01 Jun 11, 2015 7:39 AM
    neelsen01 neelsen01 Jun 11, 2015 8:37 AM Flag

    I'm thinking ph 3 gets started towards the Fall. I could be wrong though with Dr Frost in the mix. He may help the company with the paperwork/logistics to hasten the start. Either way it looks like the way ph 3 is designed with pts taking chemo ONLY in the control group, how can we expect any different result other than the benchmark? So, in essence, Iomab can't help but to look superior just based on getting pts to HSCT in 10 days alone, much less the durable remission rate or survival rate 1st year. It's almost like Iomab has no choice but to succeed. This must be the closest sure thing a phase 3 trial has ever faced. But more importantly, once Iomab-B is approved, it will be immediately moved up to different AML groups and other related diseases to see if it's better than current treatments. If it can work in these infirmed very sick elderly patients, imagine what Iomab can do for other more healthy patients? The possibilities are remarkable.

    Sentiment: Strong Buy

  • He was the only one receptive to me months ago when emailing analysts. I have since contacted him on ATNM. Take a look at this one guys-ageninrussia- look at Iomab-B-you will be impressed. Phase 3 skewed toward success as patients MUST take chemo in the control group.

    Sentiment: Strong Buy

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