Insmed Incorporated Message Board
-
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-
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- 1 Reply to fudfighter4
-
Mommy says call home
-
Thank you.so its 50/50
- 3 Replies to downbythewater
-
Downbythewater, how do you arrive at a 50/50 probability of success in the Arikace clinical trial?
-
Terry - why don't you answer? How did you arrive at 50/50?
-
How do you arrive at that estimate?
-
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.- 1 Reply to fudfighter4
-
do you really think anyone believe this crazy junk?$5.6 billion, anticipated peak sales of 2.15 billion is for idiots.Arikace will be a third tier drug if they get CF through.NTM,my opinion is it fails.My opinion is far more realistic and the price now should be proof enough.
-
The last safety test is Phase3.The 2009 HGSI trade and this one completes your #$%$ post for today.
I will be posting your fabrications and lies
-