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  • 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 01:34 PM | 1 Like Like |Link to Comment
  • Horizon Pharma Continues Cash Burn And Dilution [View article]
    I shouldve clarified. More than doubled outstanding shares in 12 months.
    Nov 8 12:56 PM | Likes Like |Link to Comment
  • Quick Take On Geron's Imetelstat Abstract [View article]
    They cancelled the breast cancer stuff. Anyone following the RNA space, knows oligos are not suited for solid tumors.

    Company has already said they do not have any plans for the further development of imetelstat for multiple myeloma.
    Nov 8 12:46 PM | Likes Like |Link to Comment
  • Horizon Pharma Continues Cash Burn And Dilution [View article]
    Certainly some short term pain.

    How did it work out for you last time when the CEO diluted the company by 100%+?
    Nov 8 10:04 AM | Likes 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 09:53 AM | 1 Like Like |Link to Comment
  • Horizon Pharma Continues Cash Burn And Dilution [View article]
    A very odd world we live in when a drug like this does $26M in sales. Both of its components are generic. DUEXIS offers no benefit in dosing either.

    Good job by the sales team. Sure surprised me.
    Nov 8 09:31 AM | Likes Like |Link to Comment
  • To Myriad Investors, Your Risks Are MyRisks [View article]
    The share price for Myriad has declined more precipitously than it's peers, which to us means that the price action has some fundamental basis outside of the macro-events in the biopharma sector.

    We stand by our short-thesis, and at least in this short-term our thesis has been confirmed. We are not confident in Myriad's long-term prospects and our overall short-thesis remains.

    An interesting entry point may be between 1.25 to 1.5 billion dollar market cap.

    We hope our insights have helped you profit or at the least, helped with risk mitigation.
    Oct 12 04:21 PM | Likes Like |Link to Comment
  • To Myriad Investors, Your Risks Are MyRisks [View article]
    I wouldn't worry so much at AMBRY, or Gene-by-Gene, or Quest, or LabCorp, as if that wasn't enough competition. If I were an investor, I would worry about every academic center in the country.

    Thanks for your comments.
    Sep 12 10:51 PM | 2 Likes 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 10:49 PM | 1 Like Like |Link to Comment
  • BioCryst: I Am Bullish On The BCX4161 Story [View article]
    Totally underplays the bleeding risk with this drug as well.
    Aug 28 09:40 AM | Likes Like |Link to Comment
  • BioCryst: I Am Bullish On The BCX4161 Story [View article]
    Actually believe it was a lot more pills than 3 pills 3 times a day, think it was more like 4-6 pills 3 times a day.
    Aug 27 11:36 AM | Likes Like |Link to Comment
  • After Phase III Failure, Celsion Is Still Worthless [View article]
    It doesnt work. The PFS curves were identical.
    Aug 16 09:55 AM | Likes Like |Link to Comment
  • Don't Short Myriad Genetics Ahead Of Earnings [View article]
    Good luck to them with over a dozen companies launching competing BRCA testing.
    Aug 15 09:22 AM | Likes Like |Link to Comment
  • Quick Take On Vical's Allovectin Failure [View article]
    Appreciate the comment. We strive to provide independent analysis.
    Aug 13 10:44 AM | 3 Likes Like |Link to Comment
  • After Phase III Failure, Celsion Is Still Worthless [View article]
    Thermodox does not work. The company's recent claims don't fly with us.
    Aug 12 01:20 PM | Likes Like |Link to Comment
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