I think it's great that you spoke with your formulary, good for you, although I know you could not name said formulary because you actually spoke with no one.
The World Health Organization classifies pulmonary hypertension into five groups, with the first being Pulmonary Arterial Hypertension - PAH. Tracleer is for this WHO class 1 group and pricing is listed at around 8500.00 per month regardless of what your formulary says. INS1009 is designed as a WHO class 1 drug also. Your point is wrong.
INS1009 has not even started a phase I trial yet, but has already spoken with the FDA regarding a 505(b)(2) filing if they get to that point. Tracleer has some pretty rough side effects. The smaller 7 billion dollar market cap UTHR got tyvaso to market in 2010. Tyvaso is inhaled 4 times daily and is intended to have fewer potential side effects than Tracleer, but causes an awful cough..... four times a day. Still, it's sales top 400 million. INS1009 is intended to be used just once daily and in animal studies has caused virtually no coughing. Insmed has a long way to go, but this is an enormous market in terms of dollars.
I skipped talking to my formulary and just did some homework.
I always like to look at leading gainers in biotech, and a few days ago ZSPH led the pack. The company had cancelled out of a conference starting buyout rumors, later confirmed. 15 billion Swedish drug giant Actelion has been in talks to purchase the company. I checked out Actelion and was really surprised to find out that there leading drug by far is Tracleer, for the treatment of Pulmonary Arterial Hypertension - PAH. Sales for Tracleer, now off patent, border on 2 billion! Insmed expects to start a clinical trial for INS1009 in Q4 for the treatment of PAH and believe they may qualify for a 505(b)(2) path to approval. I wasn't aware of the sales potential for this drug using the Insmed platform that is hardly discussed here.
"Will never be able to compete in the Europe. Novartis has pricing pressure." You must have read an article or something that says that antibiotic resistance is no longer a problem. The article is wrong. Nice try.
The company doesn't list any revenue projections so whoever is saying over and over that the company dropped revenue projections for CF is......right.....I guess.
The European app is for NTM and CF, so with approval the company can market LAI for just NTM or both, it will be entirely up to Insmed management.
The most important info provided is the one year post 112 study data. Of the total 23 patients given both LAI and placebo that converted, just one died. Of the 66 that did not convert 9 have already died. That type of info makes it pretty clear that culture conversion should have been the focus from the beginning.....
Actually I responded to that post admitting that they could be effective against NTM but were involved in no clinical trials for NTM. That said, one of the warnings on the bedaquiline label is death, which is a strong no no with the FDA. Both of those things being said, claiming to be a clinician is nearly as funny as the thought of you actually advising "about a dozen" others. ... And finally, yes, there are many drugs in study, but not for NTM. bye, bye
Checks, when I go to clinicaltrials.gov and type in NTM I find many trials attempting to determine who has NTM and who is likely to develop NTM, but I only find one drug being trialed - LAI.
So I went to the American Thoracic Society site and they only show one drug being trialed for NTM - LAI.
So if the afternoon session is all about clinical developments of drugs to treat the disease, then it seems to me like the afternoon session is all about LAI. What gets me curious is that something whack job will never mention is the six month surrogate primary endpoint of culture conversion can qualify LAI for accelerated approval.... The meeting seems to be scheduled about 6 months after the trial got going. Coincidence?
Too funny, that really did make me laugh out loud.... "pretending to challenge Terry", I've been asking him to actually challenge me for two years now, which reminds me that I left out that he is a wimp, and yes you are Terry and calling me a jerk is like winning the lotto!!
Jad, I'm sidelined for a few days and don't have much to do but watch tv, read, or rip Terry..... While his true motives are not known, any logical person knows this:
He doesn't really surf, at least not on water. All the innovations in technology don't yet include a device that can be used to post on a surf board, and he is always, always here.
He doesn't know how to actually short a stock. His post a few years ago about the abolished uptick rule made that absolutely, abundantly clear.
He is totally obsessed with Kevin. (I find that somewhat scary)
A single word,,, iPLEX, drives him into a complete frenzy. I don't know, maybe he is like five foot one and couldn't wait until he could use the drug which was then pulled?
He isn't very creative, as is obvious by his reposting his own messages over and over.
He has multiple ID's, your last post receiving multiple thumbs down within minutes make that obvious.
We could all put him on ignore, but in a weird way I get some comedy relief nearly every time he puts up a post.
He has no friends. How could someone that spends the middle of the night until the following evening have time for friendships?
He remains the only person in my years of reading message boards that carries on conversations with..... himself.
I doubt if this even touches the surface of bizarro boys true nature.....
Thank you for making me look so good Terry! Yesterday I asked you for today's pick, and then said never mind, I know that you will tell us today after the fact.....and you just did exactly that!!! Exactly! I love it when you make me look smart!!!
Wow Checks, I must have missed June as I never saw that post. Eyelea and Lucentis are approved for macular edema with Eyelea boosting REGN to a meager 54 billion market cap..... Of course both involve injections right into the eye and non injectable drugs would gain nearly instant market share..... Of course we have all been told that retinopathy of prematurity is the one and only possible use of IGFBP3
"to finally show the board" lol You are nearly always good for a laugh, but that takes first prize!! Come 'on king trader, whats your pick for tomorrow? I know, I know, you will tell us after the fact tomorrow.......go study that uptick rule that was abolished over 8 years ago, talk about foot in mouth!!
Part of me says that just to tick off brainboy, but seriously, this current trial is open label - if cultures are negative the patients and the docs know if LAI was involved.... Since the study is confirmatory and if the conversions in the LAI arm are 3 or 4 to 1, then WHY NOT just stop the trial.... That is a question NTM patients are likely to ask at the October meeting
Thanks Jad, I missed that post but have noticed that recently he has been dissing bwd in his postsing..... I guess that is a likely consequence to a post directed against bizarro boys honesty that had 22 thumbs up..... now 23
It sounds like they are sponsoring it. It's nice to know that when the European Respiratory Society needs someone to sponsor an award for NTM they turn right to INSM.
I've been reading the forums over on NTM News and Info and believe there will in fact be a Cry for LAI at the FDA sponsored meeting in October....
Go away clone, although it is somewhat old news IMO, at the end of May poster 612 appeared on the Insmed website and remains on the site under presentations. The number of patients that have had culture conversions is up significantly from the original report and there was a significantly positive difference in the walk test for those that had culture conversion over those that did not. The number of conversions for those taking the standard meds but placebo rather than Arikayce remained at just 4.
Funny Jad, three thumbs down.... which can only mean that after posting at 3a.m. he is still posting, changing ID's to thumbs up his posts and thumbs down yours, and then going back to his terry ID to tell us how great he is again. Crazy. I'm in the camp that the only cure is surgery, the kind I described in my post yesterday