Historian. I was the reason for the post. I wasn't the reason it was deleted..That I do not know. While I did
ask for all imput, and really have no issue with Terry's response since he was clear, and civil. I don't profess
to know all, or should I say remember all of the matters surrounding Iplex, I do remember some of the
studies done prior to the settlement agreement. I did have conversations with members of the medical
team, after their official retirements from the company. I did not ask if they where under confidentiality agreements, and they did not offer a position on the matter. I tried to contact Dr. Allen prior to his death,
and he was under a non disclosure agreement. My feelings about this molecule is based on the things I
was made aware of prior to the agreement.
I do understand Iplex is not central to INSM's approach to revenues at this time, but I do believe that
eventually it will be a component in their arsenal going to market. I do believe a licensing agreement will
probably be the avenue INSM takes, and I'm good with that.
Here's my feeble take on this, and I invite all that disagree to pipe in...
As far as Iplex is concerned, there is no reason for trials..Once either the legal agreement
runs out, or an partnering agreement is put In place,,Iplex could go to market. It has
already been through more than one phase three trial, and passed with flying colors.
The primary use would be for short stature. I would venture to also state I feel Iplex
could get a fast track for compassionate use for ALS...
Ok guys...shoot away...I'll hold still
I've always wondered about these numbers..Especially when I look at the Morgan Stanley number.
I personally own over 80,000 shares of INSM..I've asked myself if my shares are reflected in their
holding numbers...Or if the shares reported to them are held in their own discretionary trading
I won't jump into the income recognition conversation simply because there isn't enough of it now
What I will offer my own take on is without question Lewis and Company missed their timing targets
on this study. This is the second miss with this company in the last couple of years. That causes me
to believe they won't miss again. If anything, the overviews I read in the earnings call transcripts
seem to without question state that management has taken note of this miss, and are steeing to
be more conservative on future outlooks. Even to the point of being able to over perform on some
fronts. I wouldn't be surprised to find the company actually exceeds some of the timelines they have
laid out simply because they know they have to...Their credibility is at stake. I assure you many of
the funds that made recent investments here aren't very happy about this. You add this delay to the
downdraft in bio stocks lately, and this is a big blunder.
We do notice, that not only did Lewis recognize this, but more muscle in the form of a clear market
leader in this field was brought on board. While I don't like the setback, I think I see some logic to
much of what has been said, and will add more shares if it drops further.
I noticed someone deleted their input to this discussion,,I wish they hadn't...There was some
value there..I would like to add to this thread the following comment from the quarterly conference.
I know some will shoot down the relevance of what Mr. Lewis is saying, or they may fail to really
interpret his point..but I've noticed this vague inference in prior conversations. Draw whatever
conclusions you like, but I see something of value here.
With respect to our fourth goal, and our earlier stage pipeline, here, too, we remain on track. Last month we submitted our IND for INS 1009, and we expect to begin a Phase I study later this year. We are also advancing several other research projects, and expect to share some details in the coming months, after we further validate our initial findings with additional pre-clinical data.
Okay. On the EMA, you asked NTM only and the strategy there and why step away from CF? The similarity challenge is what provoked our belief that it would be wiser to return to CF at some point in the future. Again, we hit our primary endpoint on the phase 3 study across Europe in CF. By setting aside that opportunity for now, it enables us to focus our resources on NTM. Obviously, there’s a lot going on at the company but I think this is also the right strategic move when we look at where we end up if we can secure NTM approval in Europe. This is an appropriately unmet medical need that this drug we think is going to make a material difference in. Some of the best examples of the regulatory posture with regard to that at least on a country basis can be seen in France where the ATU approval, which is getting reimbursed at around $60,000 a year shows that there is both a recognition of the need and a support for the use of this drug. And I think that is probably the best harbinger of what the commercial opportunity we think is for ARIKAYCE in the treatment of NTM if it’s approved across Europe. Does that answer your question? I think CF is off the table for now. There is the opportunity to return to it, but I think in a world that is genericizing inhaled CF antibiotics is not the area of greatest unmet medical need and that’s what driving our decision.
A01Pulmonary Nontuberculous Mycobacterial Infections:
Healthcare Resource Utilization and Costs in Medicare
Patients at a U.S. Health Plan
Abraham K1, Dufour R2, McDermott K3, Tarr A2. 640 Eden Park Dr.,
Cincinnati, OH 45202; firstname.lastname@example.org; 513.826.7210
1Humana; 2Comprehensive Health Insights; 3Insmed
BACKGROUND: Pulmonary nontuberculous mycobacterial (PNTM)
infections are difficult to diagnose, since their symptoms (e.g., cough,
dyspnea, hemoptysis and fatigue) are common in other respiratory
comorbidities. These overlapping symptoms may mask the infection,
delaying diagnosis. PNTM infections are increasing among patients
65 years old and can exacerbate deterioration of lung function,
compounding respiratory problems for some patients with serious
comorbidities. PNTM infections are challenging to diagnose and treat,
which can lead to prolonged treatment with multiple antibiotics as
well as increased resource utilization and costs.
OBJECTIVE: Pre- and post-diagnosis resource utilization and costs for
patients with PNTM infection and matched controls were examined.
METHODS: Using Medicare medical and pharmacy claims between
January 1, 2007, and May 31, 2014, patients with PNTM infection
(defined by ≥ 2 separate medical claims for PNTM infection
[ICD-9-CM 031.0]) (n = 738) and matched controls (n = 5,166) were
identified; first diagnosis served as index date. Both groups had ≥ 18
months of continuous enrollment pre- and post-index. Patients with
PNTM infection were further split by those treated with ATS/IDSA
guidelines-based antibiotics (n = 214) and those not treated (n = 524).
Resource utilization calculations were completed for each group
of patients on 8 categories (e.g., Inpatient Stays, Outpatient Visits).
Healthcare costs were computed using the allowed amount and were
reported in 2013 dollars for all medical, pharmacy, and total (medical
+ pharmacy) costs.
RESULTS: Pre- and post-diagnosis resource utilization was higher
across all service categories for patients with PNTM infection than
for matched controls (P
You are right..bio's are getting knocked down again..shorts are working the entire sector..this has nothing
to do with INSM...good place to buy more..as far as Major Pharma buying,,could be, but based on volume
they're not getting much.
To go to INSM's website, and read the latest presentation. Very compelling. You might find another
nugget of value there. INSM talks about a new area of interest that takes no additional investment,
has a large unmet need base of patients, and requires little new effort..guess what that is?
It's your company..go and see for yourself..
I tried to post this, but there is a link attached that can't be transposed to this board. It appears as though
they are revealing new information, and an update to their studies..
Every bio stock I have is getting hammered..some of my bank stocks are taking it on the chin also..my
energy holdings have actually stopped sinking..now there's a reason for scotch..There is no INSM specific
news out there, so this isn't about INSM..Talked to my folks at MS..They say this is something I'm just going
to have to be patient about..They actually expect the market to end the year up..Hell,,I wasn't going to spend
the money right now anyway..so,,no worries..