Insmed Limited; Treatment of Mycobacterium avium Complex (MAC) lung disease in
adult patients who have persistent positive sputum cultures despite the use of medically
appropriate first-line therapy
Scope: Oral explanation
Action: Oral explanation to be held on 24 May 2016 at 14.00.
List of Outstanding Issues adopted on 25.02.2016. List of Questions adopted on
After some delay , I was able to hear the tail end of the presentation and questions. He said enrollment in CONVERT was going very well and surprisingly so in Asia. Nothing else really new from answers to other questions. I almost pulled the buy trigger this morning, but I see now we have headed up with XBI, (for now).
As a fellow (part-time) musician, I know you have a rich life apart from this board. I didn't bet the farm on this stock, though my holdings are substantial and luckily I bought when prices were much lower and I am still way green. I know that nothing is guaranteed,and that's exactly what you realize when you cast a fishing line into waters that even you think you know fairly well. I like sitting in a boat waiting for the bite. You could be listening to Elgar or Vaughan-Williams in the interim. So enjoy all that is at your disposal and enjoy not engaging a very sick person who we should pity and hope for their eventual recovery and redemption.
Some interesting comments from the 10k:
In addition to our patents and trade secrets, we have filed applications to register certain trademarks in the US and/or abroad, including INSMED, ARIKAYCE, and IPLEX.
In May 2012, we entered into an agreement with Premacure pursuant to which we granted to Premacure an exclusive, worldwide license to develop manufacture and commercialize IGF-1, with its natural binding protein, IGFBP-3... get that...MANUFACTURE.
Funny that they would call the study "pre-clincal" as LAI has been in the clinic for years. Threw me off. I thought they were starting to work on another disease.
From the press release, Data accepted for presentation at ATS 2016: (iii) a preclinical study of ARIKAYCE.
Any guesses as as to what indication they are targeting?
I live on a long and winding gravel road. One of my neighbors had this dog that had a sport of chasing every vehicle that came along. I found a way of breaking him of that habit. I just shifted into low gear and kicked up a cloud of dust which enveloped him every time he chased me. He soon tired of breathing in all that dry dust and gave it up, just like TIP users eventually will, it it irritates them too.
Arikayce is likewise differentiated from TOBI, carried in lung-friendly surfactant actually made of the same stuff native to human lungs. Arikayce for Ps in CF will be revisited sooner rather than later.
How about the study using iPlex in which the authors claim the therapy "represent(s) a paradigm shift for the treatment of muscular dystrophy as well as a host of other disabling and devastating muscle diseases." The title is "Triggering regeneration and tackling apoptosis: a combinatorial approach to treating congenital muscular dystrophy type 1 A," so a google search should pull it up. I wonder if there is any follow-up on this work published in the journal, Human Molecular Genetics in June 2013. And don't forget, the company itself listed ALS as one of the orphan diseases it might address in the future and this would undoubtedly revolve around iPlex, which is Nature's own regulator of cell growth and regeneration. Genentech didn't fight for the rights to this compound for nothing and we own it in 2017.
My prediction is that we will find out tomorrow whether they are or they are not on the agenda for April.
I think you're right. The "glass-half-empty" troll has shown uncharacteristic silence. Correction: "glass-fully-empty" like his brain and his life.
At least the company still exists as an entity. Personally, I think the ultimate deal, the reverse merger, had everything to do with what both pre-existing entities brought to the table. That, yes, means iPlex was part of the equation. The paltry cash position of INSM at that time surely was not the inducement. It was all a matter of waiting out the expiration of the settlement. Unfortunately, it has taken longer than expected to bring that "near term opportunity" (aka Arikayce) to market. There are many bumps along the road, but I still believe we will score on both accounts.
LOL...I see my original post on this subject, which was met with a salvo of accusations of being a fraud, a sissy, kvnmcdd, among other lewd, unmentionable things, has been deleted. At the risk of provoking another spectacular outburst from the self-appointed board guru of chart technical analysis, I will note that so far, the pattern is holding up quite well. Today's swoon took us exactly back down to the neckline of the H&S pattern, which we broke above on April 4. According to stockcharts wbsite, which has a good free tutorial on the subject, this retest is quite common. We also filled a small gap created by the April 6 opening trade by hitting 12.66. I do not purport to be a genius technical expert, but the price action so far seems to fit the well-known and described pattern to a tee. Only time will tell if we continue our upward trajectory to the measured target of 15.97, a clear area of former support where we will probably have more work to do to move upward.
Great work. Another point. The troll always stresses the fact that CF is an exclusionary factor in the current pIII NTM trial. As if that would exclude CF patients with NTM from legal access to Arikayce. Did it ever occur to the dolt that Insmed wanted to see the effect of Arikayce on individuals infected only with MAC without the complications presented by CF? It's a cleaner trial with fewer intervening variables. If it's clear that Arikayce is effective against MAC, absent other complications, then it's pretty clear that Arikayce could be useful against NTM in the CF population, especially since it was proven to be essentially similar to the tobramycin competitors in a pIII Ps CF trial. Hmmmmm.
OK, I'll spell it out for you genius. Left shoulder: 2/26 low= 11.42. Head: 3/17 low= 10.53. Right shoulder 3/29 low= 11.08.
It looks like they did not immediately respond to list of outstanding issues and requested an extension of the clock stop. There is no mention of Amikacin/Arikayce in the March 29-April 1 2016 meeting, so I guess the soonest chance to address the LOI is at the meeting later this month (?). Maybe biowatchdog can chime in.