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SIGA Technologies, Inc. Message Board

beavertail_splash 2825 posts  |  Last Activity: 4 hours ago Member since: Apr 13, 2007
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  • Reply to

    INCY has to be in the cross hairs

    by mrdtino Aug 25, 2014 10:10 AM
    beavertail_splash beavertail_splash 4 hours ago Flag

    ...what about CTI BioPharma Corp's JAK2 inhibitor pacritinib`s FTD this past August? Any viability there?

  • beavertail_splash beavertail_splash 4 hours ago Flag

    To tell the truth there wasn't much to see over in CTI BioPharma Corp either when they got the FTD earlier in August. Their SP only moved by $0.15.

  • beavertail_splash beavertail_splash 13 hours ago Flag

    The Food and Drug Administration (FDA) has developed four distinct and successful approaches to making such drugs available as rapidly as possible: Priority Review, Accelerated Approval, Fast Track Designation, and breakthrough therapy designation. Because each of these approaches implies speed, there can be confusion about the specific meaning of each and the distinctions among them. FTD is NOT the same as BTD. In this case they are going against Jakafi for spleen reductions, not remissions as in Imetelstat.

  • beavertail_splash beavertail_splash 13 hours ago Flag

    ...remissions are not even considered in their trial design. Another INCYTE-like 'comfort' drug.

  • beavertail_splash beavertail_splash 13 hours ago Flag

    "The primary hypothesis of the study is that treatment with either once-daily or twice-daily pacritinib results in a greater proportion of patients with thrombocytopenia and myelofibrosis achieving ≥ 35% reduction in spleen volume from baseline to Week 24 than treatment with Best Available Therapy, and a greater proportion of patients achieving a ≥ 50% reduction in total symptom score from baseline to Week 24 as measured by the Myeloproliferative Neoplasm Symptom Assessment Form 2.0" sounds like another version of ruxolitinib.
    "Further study details as provided by CTI BioPharma:
    Primary Outcome Measures:
    Efficacy [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]
    To compare the efficacy of two dose-schedule arms of pacritinib (pooled once-daily and twice-daily dosing arms) with that of Best Available Therapy in patients with thrombocytopenia and primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis; the efficacy measure for this analysis is the proportion of patients achieving a ≥ 35% reduction in spleen volume from baseline to week 24 by magnetic resonance imaging (MRI) or computed tomography (CT) and the proportion of patients achieving a ≥ 50% reduction in total symptom score from baseline to Week 24 as measured by the Myeloproliferative Neoplasm Symptom Assessment Form 2.0.
    Secondary Outcome Measures:
    Efficacy [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]
    To compare the efficacy of once-daily pacritinib with that of Best Available Therapy, as assessed by the proportion of patients achieving a ≥ 35% reduction in spleen volume from baseline to Week 24 by magnetic resonance imaging (MRI) or computed tomography (CT) and the proportion of patients achieving a ≥ 50% reduction in the total symptom score from baseline to Week 24 on the Myeloproliferative Neoplasm Symptom Assessment Form 2.0.
    Efficacy [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No

  • beavertail_splash beavertail_splash Aug 27, 2014 12:07 AM Flag

    The only player visible for the last few days was Lizzie Borden. Today vol increased but SP barely held it's own. The trading supports gaming the SP as you have explained but there are few buyers in this increased vol.

  • Reply to

    chrisclub and Occam's Razor: A Modern Day Fable

    by alphapsyche Jul 31, 2008 6:40 PM
    beavertail_splash beavertail_splash Aug 25, 2014 12:07 AM Flag

    ...you've been in this space fur 8 years ...a long time to be underwater.

  • beavertail_splash by beavertail_splash Aug 24, 2014 2:03 PM Flag

    Roche agreed on Sunday to buy InterMune, sells a drug to treat a deadly lung disease, for $8.3 billion. Their only drug pirfenidone treats idiopathic pulmonary fibrosis, a fatal scarring of the lungs.
    This could be GERN down the road. IMETELSTAT has shown to reverse scaring of bone marrow.

  • Reply to

    Website

    by kanderson67 Aug 15, 2014 3:52 PM
    beavertail_splash beavertail_splash Aug 23, 2014 9:19 PM Flag

    Changing the approach to treating cancer
    Developing novel, first-in-class therapeutics
    Working with passion fruit, integrity & true innovation
    Targeting major unmet medical need
    ...all seems on target cept for the passion fruit...Chippy prefers Californian nuts

  • Reply to

    New biz rule

    by sigakingone Aug 23, 2014 7:37 PM
    beavertail_splash beavertail_splash Aug 23, 2014 8:58 PM Flag

    Second guessing the Wilmington Court's decision in applying the law in this case has been a popular board pastime for the past 8 years. Most always guessing the outcome wrong. Been out for the last few years but morbidly curious as to how such a litigation fiasco could have ever taken place. 2 more years will make it a decade.

  • Reply to

    ASH 2014 question

    by trailblazer1777 Aug 23, 2014 10:38 AM
    beavertail_splash beavertail_splash Aug 23, 2014 4:15 PM Flag

    True a remission isn't a cure but to a cance patient it means a longer extended life. JAK2 inhibitors have yet to show any remissions and at best show very limited efficacy yet ruxolitinib was fast tracked and it's use in many other indications PV under review has expanded with weak supportive efficacy data..

  • Reply to

    ASH 2014 question

    by trailblazer1777 Aug 23, 2014 10:38 AM
    beavertail_splash beavertail_splash Aug 23, 2014 4:05 PM Flag

    "This might suggest they know something about the sweat spot of the imetelstat mechanism of action." E2W, I always felt the sweat spot was owing the stock?

  • Reply to

    ASH 2014 question

    by trailblazer1777 Aug 23, 2014 10:38 AM
    beavertail_splash beavertail_splash Aug 23, 2014 11:40 AM Flag

    "under the guise" ...was thinking the same thing E2W

  • Reply to

    A RADICAL IDEA--

    by golflogo Aug 23, 2014 10:38 AM
    beavertail_splash beavertail_splash Aug 23, 2014 11:38 AM Flag

    Why buy INCY...they have no cure, no remission or clinical improvements? For comfort you'd be better off buying a lazy boy.

  • Reply to

    GERN, ASTY, INCY SP & Techy talk

    by beavertail_splash Aug 22, 2014 11:37 PM
    beavertail_splash beavertail_splash Aug 23, 2014 11:32 AM Flag

    INCY does own this space and perhaps part of the FDA review panel ensuring it's monopoly of the $300mil/annum MF market.

  • Reply to

    GERN, ASTY, INCY SP & Techy talk

    by beavertail_splash Aug 22, 2014 11:37 PM
    beavertail_splash beavertail_splash Aug 23, 2014 11:27 AM Flag

    What are the next Catalyst in these stocks set to send SP higher?
    GERN; Geron’s Imetelstat provides biotech investors a unique opportunity to invest in a drug in which disease modifying activity is already established and there is no competition in sight.
    1. The lift on the Mayo Clinic myelofibrosis partial clinical hold practically guarantees the hold will be lifted off Geron sponsored myelofibrosis Phase II trial initiation.
    2. initiation of Geron myelofibrosis trial
    3. expanded disease indications ( blast & AML)
    4. partnership.

    ASTY; Promising pipeline in stem cell products.
    1. AST-OPC1 – Glial
    Cells Current development focus:
    Spinal Cord Injury 12,000 new cases per year in U.S. Phase I Trial completed in U.S. 5 Patients treated – no serious adverse events related to the OPC1 drug product to date.
    Additional potential markets:
    Multiple Sclerosis (“MS”) 180,000 new cases per year in U.S. Proof of principle achieved in animal models.
    2. Canavan's Disease(2) Rare Proof of principle achieved in animal models.
    Stroke 800,000 new cases per year in U.S. Pre-clinical research.
    3. AST-VAC2 –
    Dendritic Cells Current development focus:
    Non-small Cell Lung Cancer 166,000 new cases per year in U.S. Cells derived and characterization studies performed (parameters analyzed showed normal cell functions in vitro(3)).
    Proof of concept established in multiple human in vitro(3) systems. Scalable manufacturing methods under development.

    INCY; (FDA) has accepted New Drug Application (sNDA) for ruxolitinib as a potential treatment of patients with polycythemia vera (PV) based on lack luster results from the RESPONSE Phase III trial. Although ruxolitinib has cornered the market wrt MF; offering some symptomatic relief, it has many serious side effects resulting in many patients discontinuing. The FDA keeps approving it's expanding indication applications based on weak "Comfort" trials rather than emphasizing efficacy wrt obtaining CR's and PR's.

  • beavertail_splash by beavertail_splash Aug 22, 2014 11:37 PM Flag

    GERN; $2.32 flat below SMA 200, 50 & 20 following strong downward trend line from Dec 2013.($2.00 by Sept.1 ) Shorts 15% Target Price $4.13 insider trading several smaller sells in April/May one large purchase by BoD member in May. 1/6th average vol.
    ASTY; $2.40 down $.03 average vol.
    INCY WINCY SPIDER.
    INCY; $50.65 up $.46 below SMA 200, 50 in gradual upward channel. Shorts 6.5% Target price $70.77 insider trading consists of options being exercised as sales. no purchases. 7/11ths average vol

  • beavertail_splash beavertail_splash Aug 21, 2014 8:16 PM Flag

    The last partial hold release on the MF MAYO trial in June was preceded with a spike in vol, and increase in SP due to seepage. Neither are present this time yet.

  • beavertail_splash beavertail_splash Aug 21, 2014 7:58 PM Flag

    thanx fur the words of encouragement, I think....GULP! ;=3)

  • beavertail_splash beavertail_splash Aug 21, 2014 6:13 PM Flag

    I agree E2W the bol bands are tightening around my neck meaning it's getting harder to breath. A big move in either direction; either I'll drop dead from asphyxiation or break loose from this noose and breath a lung full of fresh air.

SIGA
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