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  • Vivus: Is the Ship Sinking? [View article]
    How can the ship be sinking when it's losing so much weight??
    May 21, 2010. 07:33 PM | 2 Likes Like |Link to Comment
  • The Decline of Google [View article]
    Umm, facebook was cashflow positive in 2009 and is anticipated to be profitable in 2010 with up to 2B in revenue. When it IPOs, it may be an "investable" company.
    May 18, 2010. 01:11 PM | 2 Likes Like |Link to Comment
  • Oncolytics Biotech, Inc.: An Intro To These Next Few Crucial Weeks [View article]
    Guess we were right after all...
    Jan 3, 2014. 01:54 PM | 1 Like Like |Link to Comment
  • To Myriad Investors, Your Risks Are MyRisks [View article]
    The CMS just cut their reimbursement rate by ~50%. Not a positive development going forward.
    Dec 5, 2013. 01:43 AM | 1 Like Like |Link to Comment
  • Quick Take On Geron's Imetelstat Abstract [View article]
    Per your reference to the CC, here is Scarlett's quote

    "John A. Scarlett - Chief Executive Officer, President and Director
    Well, I'm not going to talk about the considerations in these data, but what I can say is that the IWG criteria for myelofibrosis is pretty clear. It's quite clear that CRs and PRs are intended to signify a disease modification and to achieve a CR, PR, clearly, you have to achieve other components of the response, the remission beyond pure bone marrow morphology, et cetera. So these are found in the blood paper in 2013 and include resolution of symptoms, spleen and liver not being palpable, and so forth. So I would just refer everyone to that paper."

    Now, please read the actual criteria for CR's

    "1. Complete remission (CR)

    i. Complete resolution of disease-related symptoms and signs including palpable hepatosplenomegaly.

    ii. Peripheral blood count remission defined as hemoglobin level at least 110 g/L, platelet count at least 100 × 109/L, and absolute neutrophil count at least 1.0 × 109/L. In addition, all 3 blood counts should be no higher than the upper normal limit.

    iii. Normal leukocyte differential including disappearance of nucleated red blood cells, blasts, and immature myeloid cells in the peripheral smear, in the absence of splenectomy.*

    iv. Bone marrow histologic remission defined as the presence of age-adjusted normocellularity, no more than 5% myeloblasts, and an osteomyelofibrosis grade no higher than 1."
    Taken from here
    http://bit.ly/1be30Pl

    Then read the abstract again, it says specifically

    "Overall response rate was 44%. This included five (28%) patients who met the *BM* and *peripheral blood morphologic criteria* for CR (n=4) or PR (n=1) and 3 patients with clinical improvement, pending validation of response duration and resolution of drug-induced grade-1 thrombocytopenia. The four (22%) CR patients experienced reversal of BM fibrosis and recovery of normal megakaryocyte morphology. Two CR patients were transfusion-dependent at baseline and became transfusion-independent. Complete molecular responses were documented in 2 CR patients: one had U2AF1Q157P and 10% JAK2V617F and the other SF3B1K666E and 50% JAK2V617F. A third CR patient had a >50% reduction in U2AF1 469_insAGTATG mutation. Among 13 patients with leukocytosis, 10 (77%) normalized their count or had >50% reduction. *Eleven (61%) patients had complete or partial resolution of leukoerythroblastosis*"

    You see no mention of "Complete resolution of disease-related symptoms and signs including palpable hepatosplenomegaly". Hence, it does not meet the official criteria for a CR yet.

    Additionally, President and CEO of Moffit confirmed these are not true CR's.

    http://onforb.es/1be315B

    We think it could be a very promising therapeutic option. We want to see longer follow up data.
    Nov 8, 2013. 01:34 PM | 1 Like Like |Link to Comment
  • Quick Take On Geron's Imetelstat Abstract [View article]
    We have no position, long or short. Actually think it is a promising program, but believed some clarification was needed. We will actually be at ASH, so we look forward to seeing the data.

    Re dilution/funding - Imetelstat is a very expensive drug to produce(think SRPT eteplirsen) and if they intend on running a large follow up study, will need to scale manufacturing. Read their risk assessment on it. Just look at their burn rate for 2013! They arent even running any trials at all.

    "We may not be able to manufacture imetelstat at costs or scales necessary to conduct our clinical trials or potential future commercialization activities.

    Imetelstat is likely to be more expensive to manufacture than most other treatments currently available today or that may be available in the future. The commercial cost of manufacturing imetelstat will need to be significantly lower than our current costs in order for imetelstat to become a commercially successful product. Oligonucleotides are relatively large molecules produced using complex chemistry, and the cost of manufacturing an oligonucleotide like imetelstat is greater than the cost of making typical small-molecule drugs. Our present imetelstat manufacturing processes are conducted at a relatively modest scale appropriate for our ongoing Phase 2 clinical trials and investigator-sponsored trials for which we provide clinical drug supply. We may not be able to achieve sufficient scale increases or cost reductions necessary for successful commercial production of imetelstat. Additionally, given the complexities of our manufacturing processes, the resulting costs that we incur to conduct our clinical trials may be higher than for other comparable treatments, requiring us to expend relatively larger amounts of cash to complete our clinical trials, which would negatively impact our financial condition and could increase our need for additional capital."
    Nov 8, 2013. 09:53 AM | 1 Like Like |Link to Comment
  • To Myriad Investors, Your Risks Are MyRisks [View article]
    Thanks for commenting. With all due respect, in what world do you think the ACA is a win for MYGN? I am very curious to the logic of that.

    The ACA is a give away to insurance companies to RE-negotiate rates with providers and labs under the guise of "new coverage." In case you haven't noticed, LESS, not more, insurers are participating in these exchanges, and several more large insurers, like AETNA have announced that they aren't participating in certain states... It turns out the requirements of preventative care coverage and costs spend controls have made these exchanges not profitable.

    No one is going to pay MYGN's exorbitant rates.

    Also, the ACA will encourage the use of academic centers for specialty care. Remember, we said these are the people who can do the testing without MYGN's special database.

    Further, all the diversification MYGN has done with the analysis business will take awhile to not suck costs.

    jacosa, thanks for commenting. I totally disagree with you.
    Sep 12, 2013. 10:49 PM | 1 Like Like |Link to Comment
  • Oncolytics Biotech, Inc.: An Intro To These Next Few Crucial Weeks [View article]
    No, we're making the assertion that likelihood is extremely low because many other programs have failed before them, not just Amgen.
    Feb 14, 2013. 03:15 PM | 1 Like Like |Link to Comment
  • Oncolytics Biotech, Inc.: An Intro To These Next Few Crucial Weeks [View article]
    Next time try presenting an objective risk-adjusted analysis that accounts for probability of success in Phase 3 and eventual approval. You'd find it's rather low.

    You still have yet to address that no viral vector for oncology has ever been approved of succeeded in Phase 3. Amgen's BioVex program canned the Phase 3 in H&N. Melanoma is ongoing with data in 1H'13, however, it's an odd comparator arm with GM-CSF. GM-CSF is not approved for salvage therapy in melanoma.
    Feb 13, 2013. 04:45 PM | 1 Like Like |Link to Comment
  • After Phase III Failure, Celsion Is Still Worthless [View article]
    We are taken seriously. We predicted failure whilst all those on SA were putting out unrealistic PFS numbers and price targets.
    Feb 12, 2013. 05:01 PM | 1 Like Like |Link to Comment
  • Oncolytics Biotech, Inc.: An Intro To These Next Few Crucial Weeks [View article]
    Keep dreaming.
    Feb 12, 2013. 12:20 PM | 1 Like Like |Link to Comment
  • More Uncertainty Ahead For Threshold [View article]
    When drugs have overlapping toxicities it is generally unwise to combine them, especially if grade 3/4.
    Nov 25, 2012. 10:47 AM | 1 Like Like |Link to Comment
  • An Analysis Of Celgene's CVR For Abraxis [View article]
    Celgene announced positive data in pancreatic cancer for Abraxane + Gem combo. Data at ASCO GI.
    Nov 10, 2012. 05:03 PM | 1 Like Like |Link to Comment
  • Multiple Catalysts Ahead For Depomed [View article]
    If you look at companies like spectrum and santarus, they have been able to take products like Gralise and grow them into the hundreds of millions in annual sales. Even $100 million in annual sales for Gralise, would value the company at about $300 million. I am sure you know that the average M&A multiple, in the past 5 years, has been between 3-5x annual sales.

    So, from a fundamental perspective, the company has room to go higher, in a 1-2 year timeframe. I think Serada is mostly a distraction and a wild card.

    Royalty revenues are a huge driver of revenue as well.

    I hope this helps you.
    Nov 4, 2012. 12:29 AM | 1 Like Like |Link to Comment
  • What's Left For Threshold? Not Much [View article]
    We would not put much faith behind such Tier 2 IBs. Research is written to get banking deals with the companies they write about. They also do meaningful institutional business, so it's important . Some are significant market makers, but the research may or may not be profitable on a stand alone basis.

    Our response to some of your items 1-8:

    -- "TH-302 has shown to be highly effective and safe."

    We disagree with your statement as stated above and in the article. As we highlighted, the AE profile is not that great and poses it's own problems to patients QoL. Effective compared to what?

    -- "The company has a strong pipeline. "

    They only have one drug in trial. They rarely speak about new candidates.

    -- "At year end it will have about $100 million in cash and NO DEBT. Thresod has a sweet partnership arrangement with one of the top drug companies in the world, Merck KGaA."

    Merck KGaA is not an ideal partner by any means. They have a history of developmental failures and poor choices.
    Oct 24, 2012. 09:59 AM | 1 Like Like |Link to Comment
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