No news, half day trading the day after Thanksgiving.......your guess is as good as anyone else's. Monday is December 1st.....Tuesday there are a couple of presentations.
Oh, my.....imagine my dilemma, Zake with you setting up a perfect comment.....utilizing the thoughts of Terry, rain, and sewers. As much as I would like to complete that comment, I will only say to Terry...that God loves you as much as anyone else here on the board and has given you a gift.....all you have to do is Believe and accept it.
.....is it safe to assume that, with the exception of October 31 and before August 2, anyone who short shares and have kept that position are now in the red? If so, may I be the first one to shout HALLELUJAH!!!???
While the share price can certainly go down tomorrow, it sure feels good right now.......LOL
That close to six million was of November 14th. My guess, and it is certainly just a guess (LOL), that there might have been some covering the past couple weeks......maybe even some yesterday?? The next short interest report won't come out until next week for the settling date of November 28th......I wish there was something more current that was more reliable.
I think you doth protest too much, Terry. You say nothing to iPlex.......some of us say there is something to iPlex.......question--what does Roche and Ipsen say about iPlex?
SAN FRANCISCO, May 1, 2006 /PRNewswire-FirstCall via COMTEX News Network/ -- Insmed Incorporated (Nasdaq: INSM) today announced results from a prospective, multicenter clinical trial of rhIGF-I/rhIGFBP-3, or IPLEX(TM) (mecasermin rinfabate [rDNA origin] injection) administered once daily to children with severe primary insulin-like growth factor-I (IGF-I) deficiency. The study showed that treatment resulted in statistically significant, dose-dependent increases in height velocity (growth rate) with a favorable safety profile. The first-year results from the 24-month study were presented in an oral presentation at the Pediatric Academic Societies' (PAS) 2006 Annual Meeting at the Moscone Center in San Francisco, CA.
In the scientific abstract presenting the safety and efficacy data for IPLEX in children with severe primary IGF-I deficiency (primary growth hormone insensitivity), the investigators reported that the mean height velocity for the dose group titrated with up to 2 mg/kg/day increased from 2.0 cm/year pre- treatment to 8.3 cm/year during treatment. Children with genetic and acquired forms of growth hormone (GH) insensitivity appeared to respond equally well to treatment. IPLEX is the only once daily IGF-I replacement therapy available for the treatment of severe primary IGFD. The once-daily dosing regimen used in the study was associated with a high compliance rate of 95% of injections taken.
"We are very pleased with the growth rates and safety profile achieved with IPLEX in this patient population," remarked Dr. Kenneth Attie, Vice President, Medical Affairs at Insmed. "Once-daily administration of the complex provided physiologic replacement of IGF-I and was well-accepted by patients and their families in the study," he added.
The safety profile of IPLEX proved favorable as instances of low blood sugar (hypoglycemia) were mostly mild and asymptomatic, with no hypoglycemic seizures reported. Patients with severe GH insensitivity have a predisposition to hypoglycemia without treatment. Of the subjects enrolled in the study, 28% reported a history of hypoglycemia prior to treatment. This was similar to the proportion of subjects (31%) who experienced at least one incidence of hypoglycemia during the first year of treatment with IPLEX, usually described as mild and asymptomatic.
In the study, no patients discontinued IPLEX due to a related adverse event. Two patients had papilledema (one with a blocked pre-existing ventriculo-peritoneal shunt and one asymptomatic). No instances of facial nerve paralysis were reported. As is common with protein therapeutics, antibodies to the protein complex were detected in most patients, but were not associated with growth attenuation or adverse effects.
IPLEX was approved as an orphan drug by the United States Food and Drug Administration in December 2005 for the treatment of growth failure in children with severe primary IGF-I deficiency (Primary IGFD) or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH.
IPLEX, a complex of recombinant human IGF-I and its binding protein IGFBP- 3 (rhIGF-I/rhIGFBP-3), is the only once-daily IGF-I replacement therapy. It is also the only FDA-approved therapy that provides both IGF-I and IGFBP-3 to treat children with severe primary IGFD. The drug, to be launched during the second quarter of 2006, is also being investigated for various other indications with unmet medical needs, including extreme insulin resistance, myotonic muscular dystrophy and HIV Associated Adipose Redistribution Syndrome (HARS).
.....earlier today Justarook posted that there were 4 job postings left. They added another one today.
Director, Regulatory Affairs Bridgewater, NJ 05-Dec-14
Regulatory Associate Bridgewater, NJ 19-Nov-14
Director, Health Economics and Outcomes Research - Global London, United Kingdom 02-Nov-14
Facilities Manager Bridgewater, NJ 02-Nov-14
Senior Statistical Programmer / Manager, Statistical Programming Bridgewater, NJ 13-Oct-14
Insmed IPLEX vs. Tercica INCRELEX product labels
Found this post from some wanderings into posts of 2006. Posted by someone else on another board.
the best marketing campaign that the sales force at insmed can do is mail out these two pages from the respective labels of the product and let the doctors and parents figure out from themselves which product they should use.
Insmed's side effects were asymtomatic to mild whereas Tecica's product side effects were mild to moderate. The only reason it didn't get any asymtomatic side effects is that it was a compassionate use study so they didn't check for them. They would have had 100 percent hypoglycemia if they did.
from the Increlex label page 11
Hypoglycemia was reported by 30 subjects (42%) at least once during their course of therapy. Most cases of hypoglycemia were mild or moderate in severity. Five subjects had severe hypoglycemia (requiring assistance and treatment) on one or more occasion and 4 subjects experienced hypoglycemic seizures/loss of consciousness on one or more occasion.
from the IPLEX label page 10
Hypoglycemia was reported in 11/36 (31%) patients in the study generally rated as mild and asymptomatic.
Yep.....thanks for this, League. You know, as much as Terry is not appreciated here, perhaps we owe him a little bit of thanks for helping us bring to light what else Insmed is all about. A few more years and the lid is off the simmering pot.
So, while we wait for the progression of Arikayce, iPlex is next.....then followed perhaps by igfbp3 and INSM-18, and more? I might not be here for the last two as I think my target price will be met before then.
......reported today after hours..........DOWN about 200,000 shares.
Avg Daily Share Volume
Days To Cover
11/28/2014 5,645,552 406,213 13.898009
11/14/2014 5,858,620 522,456 11.213614