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Insmed Incorporated Message Board

  • fudfighter4 fudfighter4 Jan 14, 2013 9:40 AM Flag

    Accumulation before and after Phase III results

    As we're now within sight of the hoped-for all-clear on the final safety study (make a special note of the word "final" - most equivalent drug candidates at this stage have yet to submit to the FDA the all-important data from the two-year rat study), and as the preliminary report from the pivotal EU clinical trial is due around mid-year, here's a reminder of how (and when) the market cap of another stock was affected both by accumulation in anticipation of favourable Phase III data and by subsequent accumulation when the data did indeed turn out to be favourable -

    Date ----------- Open -- High --- Low --- Close --- Volume

    12/23/2009 - 30.85 - 31.40 - 30.55 - 30.75 - 4,746,144
    12/16/2009 - 28.30 - 28.66 - 27.96 - 28.33 - 2,796,200
    12/09/2009 - 27.51 - 27.69 - 26.76 - 27.11 - 3,555,438
    12/02/2009 - 26.83 - 27.56 - 26.78 - 27.46 - 3,564,268

    11/25/2009 - 28.08 - 28.20 - 27.47 - 27.96 - 2,669,918
    11/18/2009 - 28.50 - 28.70 - 27.77 - 27.84 - 4,661,150
    11/11/2009 - 28.80 - 29.48 - 28.24 - 28.51 - 4,908,632
    11/04/2009 - 27.61 - 28.19 - 26.24 - 26.48 - 12,487,950

    10/28/2009 - 19.30 - 19.37 - 17.83 - 18.01 - 8,588,417
    10/21/2009 - 19.83 - 20.40 - 18.94 - 19.08 - 7,083,437
    10/14/2009 - 19.03 - 19.22 - 18.82 - 19.16 - 7,077,614
    10/07/2009 - 19.45 - 19.65 - 18.64 - 18.96 - 4,982,780

    09/30/2009 - 19.11 - 19.26 - 18.51 - 18.82 - 5,144,892
    09/23/2009 - 19.50 - 19.54 - 18.80 - 18.87 - 4,692,131
    09/16/2009 - 20.04 - 20.30 - 19.77 - 19.90 - 4,546,353
    09/09/2009 - 19.49 - 19.75 - 19.26 - 19.61 - 5,215,776
    09/02/2009 - 18.47 - 18.56 - 17.36 - 17.46 - 10,211,830

    08/26/2009 - 22.00 - 22.78 - 19.42 - 20.50 - 39,614,900
    08/19/2009 - 15.25 - 15.95 - 15.25 - 15.86 - 5,616,838
    08/12/2009 - 15.85 - 16.50 - 15.76 - 16.21 - 8,721,898
    08/05/2009 - 15.16 - 15.18 - 14.58 - 14.90 - 6,429,720

    07/29/2009 - 14.32 - 15.45 - 14.15 - 14.71 - 29,962,190
    07/22/2009 - 14.50 - 14.83 - 13.35 - 14.05 - 33,920,750

    "ROCKVILLE, Maryland, and LONDON, UK – July 20, 2009 – Human Genome Sciences, Inc. (Nasdaq: HGSI) and GlaxoSmithKline PLC (GSK) today announced that BENLYSTA™ (belimumab, formerly LymphoStat-B®) met the primary endpoint in BLISS-52, the first of two pivotal Phase 3 trials in patients with serologically active systemic lupus erythematosus (SLE)."

    07/15/2009 - 2.53 - 2.85 - 2.53 - 2.75 - 7,890,613
    07/08/2009 - 2.65 - 2.67 - 2.25 - 2.39 - 7,129,992
    07/01/2009 - 3.05 - 3.05 - 2.87 - 2.92 - 4,859,325

    06/24/2009 - 2.50 - 2.87 - 2.50 - 2.70 - 6,776,820
    06/17/2009 - 2.54 - 2.54 - 2.23 - 2.37 - 4,596,816
    06/10/2009 - 2.81 - 2.85 - 2.65 - 2.71 - 3,244,967
    06/03/2009 - 2.63 - 3.14 - 2.53 - 3.03 - 10,264,590

    05/27/2009 - 2.00 - 2.08 - 1.96 - 2.03 - 2,288,427
    05/20/2009 - 2.05 - 2.08 - 1.98 - 2.00 - 2,009,725
    05/13/2009 - 1.91 - 1.94 - 1.67 - 1.88 - 4,113,200
    05/06/2009 - 2.01 - 2.32 - 1.91 - 2.13 - 5,488,839

    04/29/2009 - 1.35 - 1.42 - 1.30 - 1.39 - 3,586,157
    04/22/2009 - 1.22 - 1.30 - 1.21 - 1.23 - 1,841,754
    04/15/2009 - 1.10 - 1.48 - 1.07 - 1.41 - 7,928,979
    04/08/2009 - 0.83 - 0.84 - 0.81 - 0.83 - 810,977
    04/01/2009 - 0.85 - 0.89 - 0.80 - 0.85 - 1,033,640

    03/25/2009 - 0.86 - 0.90 - 0.84 - 0.86 - 2,630,082
    03/18/2009 - 0.77 - 0.94 - 0.74 - 0.90 - 3,739,392
    03/11/2009 - 0.57 - 0.57 - 0.45 - 0.48 - 7,698,879

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    • Terry (downbythewater id) tells us that the odds of Arikace succeeding in the ongoing EU pivotal study are only 50/50. Terry is spouting garbage as usual - here are the study results with the greatest bearing on the likely outcome -

      1. Arikace

      From Insmed's June 13 2011 SEC filing covering the report of the multi-cycle CF Phase II extension study -

      "The data demonstrated that ARIKACE, delivered once-daily for 28 consecutive days, followed by 56 days off-treatment, for a total of six cycles, resulted in statistically significant improvement in lung function that was sustained over a 72 week period. Specifically, inhalation of 560 mg of ARIKACE produced a mean increase in pulmonary function (FEV-1) of 11.7% at the end of the 28 day treatment period of the sixth cycle (p

    • downbythewater@ymail.com downbythewater Jan 15, 2013 7:02 PM Flag

      Thank you.so its 50/50

    • I offered that HGSI price info primarily to show that the share price in March 2009 would have proved extremely deceptive to those unfortunate shareholders who used it as a basis for setting their price targets. The nine-month rise from 45 cents to $31.40 entailed a multiple of 70.

      When the share price hit $31.40 there would have been about 180 million shares outstanding - a market cap of around $5.6 billion. Anticipated peak sales of the Lupus therapy were 4.3 billion with one analyst. HGSI had a 50% ownership of the drug (GSK owned the other 50%). The market cap was about 2.6 times anticipated peak revenue.

      Although the Company did record some substantial nonrecurring revenue around that time (supplying its development-stage Anthrax vaccine to the US Government stockpile) it was otherwise incurring a substantial operating loss. The FDA subsequently responded to the Benlysta NDA with a Complete Response Letter, and for 2010 the Company recorded an operating loss of $190,773,000.

      In an 'apples for apples' scenario (apart from that operating loss) - if all goes well and Insmed was to end this year with a market cap of $5.6 billion, anticipated peak sales of 2.15 billion would equate to an expectation that Arikace will eventually be supplied to around 53,750 patients at an annual cost of $40,000.

      With an estimated 30,000 patients in the US alone with Cystic Fibrosis and a further 250,000 in the US with Non-CF bronchiectasis I wouldn't be at all surprised to see analyst peak revenue projections on that scale, provided the safety study data is clean and the Phase III data due mid-year promise an unprecedented level of efficacy, and safety, and convenience, for Arikace as a maintenance therapy for bronchiectasis.

    • The last safety test is Phase3.The 2009 HGSI trade and this one completes your #$%$ post for today.
      I will be posting your fabrications and lies

 
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