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Krispy Kreme Doughnuts, Inc. Message Board

neelsen01 397 posts  |  Last Activity: Feb 3, 2016 9:18 AM Member since: Feb 13, 2013
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  • Conference in Hawaii for transplant staff should give mgmt an indication on enrollment projections/interest. From April onward, expect a strategic move to take place at some stage either in licensing, partnering, or being acquired. Gilead CEO just stated publicly that partnerships/acquisitions are on the table now. An efficient enrollment of Iomab ph3 trial will help make Actinium attractive. Actimab enrollment will also get a boost from the conference exposure.

    Sentiment: Strong Buy

  • NCT02665065 Should begin recruiting in June( I was hoping sooner). Final data to be collected April, 2018.

    Sentiment: Strong Buy

  • neelsen01 neelsen01 Jan 22, 2016 3:40 PM Flag

    Not sure. I think it saves the company money as well though. The 21st Century Cures act should help with reimbursement and more efficient clinical trials. ODD protects the company from competition for 7 years. By that time, Actinium could be linked to CD-45 and replace Iomab.

  • "in the absence of any obvious standard
    of care, we suggest that all patients with refractory or relapsed AML be offered a referral to an
    appropriate clinical trial " - enrollment should be brisk. Look to ASH'16 for early data that could potentially lead to an early approval of Iomab-B in early 2017 if CR is doubled compared to chemo prep.

    Sentiment: Strong Buy

  • neelsen01 neelsen01 Jan 20, 2016 4:15 PM Flag

    a lot of short covering I suspect. In any case, I'm looking forward to the 1st patient enrolled in phase 3 Iomab. From there, it's just waiting on data. Early positive data could send share price over $10 no matter what the market is doing.

    Sentiment: Strong Buy

  • neelsen01 neelsen01 Jan 19, 2016 2:19 PM Flag

    It's not a company stated goal. The physicians I talked to however, feel very enthusiastic about seeing this trial get underway for the cohort of patients on Iomab's initial indication (r/r aml). Biotech selloff is creating an extraordinary opportunity for someone with patience.

    Sentiment: Strong Buy

  • This could provide enough data by December ASH presentation for the FDA to make a decision to consider accelerated approval of Iomab-B if the CR rate is at least double the control (chemo) group.

    Sentiment: Strong Buy

  • now it's time to execute the trials and follow through. Enrollment is critical. Predicting a partnership or buyout by August, 2016.

    Sentiment: Strong Buy

  • SP needs to move over $3 or Mr Seth's job may be in jeopardy. Shareholder's value can be measured only in investment return, not potential for returns. Actimab should be partnered by now. Iomab should be partnered as well despite mgmt's intention on keeping Iomab independent in the US. The stock may not be strong enough to sustain multiple share raises over the next few years.

    Sentiment: Strong Buy

  • Actimab has had slow enrollment thus far, however Iomab should be enrolled fairly quickly IMO (6-8mo) due in part to the limited options AML relaspe/refractory patients have to choose from- if they can't tolerated high dose chemo for myeloablation, they either have a choice of palliative care or enter a trial (like Iomab ph3). I expect many physicians will recommend for this trial for their respective AML patients from the promising ph2 results from the Hutch. Baring a clinical hold, we could fully enroll by July.

    Sentiment: Strong Buy

  • neelsen01 by neelsen01 Nov 14, 2015 3:20 AM Flag

    • Execute our corporate transformation from an early-stage to a later stage company
    • Initiate the pivotal Phase 3 study for Iomab-B and produce initial Data Safety Monitoring Board
    updates
    • Start the Phase 2 trial for Actimab-A and generate interim results showing proof of concept
    • Begin proof of concept studies in new indication and generate supportive data
    • Launch our fourth program based on previously announced antibody labeled with actinium-225
    • Actively explore strategic licensing and collaborations as appropriate
    • Further expand the business, technical and clinical development teams to scale with expanded
    operating plan for 2016 and beyond

    Sentiment: Strong Buy

  • Reply to

    Question for Neelsen01

    by edelhead Nov 5, 2015 3:02 PM
    neelsen01 neelsen01 Nov 7, 2015 4:20 AM Flag

    I don't think the MTD has been reached yet. We should get more clarification in Dec during ASH presentation.

    Sentiment: Strong Buy

  • Reply to

    Question for Neelsen01

    by edelhead Nov 5, 2015 3:02 PM
    neelsen01 neelsen01 Nov 5, 2015 8:14 PM Flag

    It looks like Actimab is not adding further toxicities on top ot the chemo. There's only been one CR which needs to improve as more cycles of Actimab are given during the trial. On the long end, Actimab will have to demonstrate a clear reduction in toxicities and an OS of preferably over 18 months. Anything less than a OS of 12 months may not make it competitive to current protocols due to oncologist's reluctance to use RIT drugs already (because of reimbursement and handling issues). I've talked to a couple of oncologists that have suggested as much. Iomab, however can be competitive by just doubling the CR rate (primary endpoint). By achieving a CR, a patient can go to HSCT. Mgmt is very confident Iomab can achieve this mark. Both Iomab ph3 (primary) data and Actimab ph2 data are due in 2017.

    Sentiment: Strong Buy

  • "Based on years of direct clinical observation and study, I believe Iomab-B may shift the paradigm in how AML patients are prepared for potentially curative bone marrow transplant, and it could also markedly expand the population eligible for transplant. I believe the Iomab-B Phase 1/2 clinical data demonstrate drug candidate's potential to become a very important treatment for older relapsed and refractory AML patients, most of whom have 'nothing on the treatment menu' to choose from. If successful and approved by the FDA, Iomab-B has the potential to prolong overall survival and improve quality of life in these patients with advanced disease."

    Sentiment: Strong Buy

  • Reply to

    Actinium's partnering strategy...

    by neelsen01 Oct 25, 2015 5:09 AM
    neelsen01 neelsen01 Oct 26, 2015 1:43 PM Flag

    Actimab has orphan drug designation which could make the path to approval easier. The 4th cohort data should be the next catalyst.

    Sentiment: Strong Buy

  • "Company intends to develop its products through Phase II clinical trials and it then intends to partner each drug for completion of development and commercialization with an appropriate third party. ATNM expects that its revenues will be derived from upfront payments, milestone payments and royalty payments, which payments comprise a standard structure of such partnering deals. In some markets, ATNM may seek to retain commercial rights and derive additional revenue from sales of its products."- from company website.

    Sentiment: Strong Buy

  • neelsen01 neelsen01 Oct 25, 2015 5:06 AM Flag

    Responsible Party: Actinium Pharmaceuticals
    ClinicalTrials.gov Identifier: NCT02575963 History of Changes
    Obsolete Identifiers: NCT01756677
    Other Study ID Numbers: API-01
    Study First Received: October 7, 2015
    Last Updated: October 16, 2015
    Health Authority: United States: Food and Drug Administration

    Sentiment: Strong Buy

  • The study is a multicenter, open label Phase I/II trial.
    The goal of the Phase I part of this study is to find the highest tolerable dose of Lintuzumab-Ac225 that can be given with cytarabine to patients with AML.
    The goal of the Phase II part of this study is to learn if Lintuzumab-Ac225 and cytarabine can control AML. The safety of this drug combination will also be studied.
    Lintuzumab-Ac225 is designed to deliver radiation therapy directly inside leukemia cells without giving any radiation to the surrounding normal cells
    Cytarabine is designed to insert itself into DNA (genetic material) of cancer cells and stop the DNA from repairing itself.
    Estimated Enrollment: 72
    Study Start Date: October 2012
    Estimated Study Completion Date: May 2017
    Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)

    Principal Investigator: Farhad Ravandi-Kashani, MD M.D. Anderson Cancer Center
    Principal Investigator: Jae Park, MD Memorial Sloan Kettering Cancer Center
    Principal Investigator: M. Yair Levy, MD Baylor College of Medicine
    Study Chair: Joseph Jurcic, MD Columbia University
    Principal Investigator: B. Douglas Smith, MD Kimmel Cancer Center at Johns Hopkins
    Principal Investigator: Johnnie Orozco, MD PhD Fred Hutchinson Cancer Research Center
    Principal Investigator: Alexander Perl University of Pennsylvania

    Sentiment: Strong Buy

  • to cover both Actimab phase 2,3, Iomab phase 3 plus all operating expenses and milestone payments. If management tries to raise capital through the markets, SP could dip under $1. We need a partner to cover these costs, plain and simple. The idea of going it alone with Iomab is suicidal for the SP. If management can't secure a partner, it may be best to sell either to a public or private pharma company or investment firm. Even in a fire sale we could get $10+. The political climate against biotech over the next year plus the general high valuation of the IBB index is another barrier for getting the SP up high enough to raise sufficient capital on the open market. On the positive side, if we survive to revenues, the cost of goods for Iomab are only 10% and for Actimab even less (around 5%). So the company has at least an 85% margin once both drugs are approved. FBR calculates nearly a $3 EPS on just $300M in revenue. And they only gave Iomab a cost of $65K, The company projects Iomab to be priced at $85k. More than likely by the time Iomab is approved, the cost could easily be price near $100K depending on demand from the BMT centers.

    Sentiment: Strong Buy

  • Reply to

    Actinium trifecta...

    by neelsen01 Oct 12, 2015 4:16 PM
    neelsen01 neelsen01 Oct 13, 2015 10:06 AM Flag

    I don't see why not given the unmet need (AML) and phase 2 results at Fred Hutch.

    Sentiment: Strong Buy

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