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Insmed Incorporated Message Board

jsblvbjb 24 posts  |  Last Activity: 4 hours ago Member since: Jan 19, 1999
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  • Furthermore, FDA has had face-to-face meetings with INSM recently, coming into a harmony on the path forward to NTM approval that doesn't limit any group of NTM patients, and meaning Insmed won't have to run the more expesive trial (saving our shareholders approximately 35 million bucks!)
    pianoman

    Sentiment: Strong Buy

  • Insmed per Lewis was encouraged to file for NTM approval "across" the indication, not just refractory as in the USA's targeted phase 3 trial. Reason for the difference was the success of the CF trial combined with the NTM data. US FDA appears to be very limited in its scope for granting approvals, but Insmed should have grand success in getting the FDA approval after new data is generated. So the revenues aren't going to be limited in the EU to the refractory population, meaning Lewis just gave the green light for WS to load the boat. With the application being filed by YE, there's no reason to think Insmed would ever consider a buy-out offer for anything within 10x the current price, simply based on expected revenue.
    pianoman

    Sentiment: Strong Buy

  • It just about always goes the opposite direction in short order, overall market notwithstanding. Didn't Terry just give longs a huge warning? Terry, you really should investigate the "new" data Insmed published in Europe. Long-term it's a really good case for Arikace being the top treatment antibiotic for CF. I'll say nothing more about the SP.
    pianoman

    Sentiment: Strong Buy

  • Reply to

    so jesse

    by hubby_14508 Sep 22, 2014 1:58 PM
    jsblvbjb jsblvbjb Sep 22, 2014 3:40 PM Flag

    Well Hubby, I think it's important to ignore the current share price when reflecting on the potential success or failure of Insmed which will determine the share price of the future. If I have read the data correctly, then despite today's low SP, the future share price will reflect the approvals of NTM and CF in Europe, Canada and the ROW. That SP will be many multiples of today's. If I am wrong about the new data (which is now public but never PR'd in an attention-grabbing way), and the old data were to be thrown out (far-fetched), then the current share price is overvalued by several times. The data is the most important piece of information in determining whether Insmed is a buy or sell at this time. It shows that Arikace is the first and only drug to ever show long-term success in FEV-1 for Cystic Fibrosis. This is on top of meeting its primary endpoint last year. The data shows the NTM patients in record numbers became culture-negative, when no other treatment has shown such success in 84 days. I look at today's share price, and I see a "screaming buy."
    pianoman

    Sentiment: Strong Buy

  • Reply to

    jesse

    by hubby_14508 Sep 10, 2014 10:00 AM
    jsblvbjb jsblvbjb Sep 10, 2014 4:00 PM Flag

    Hubby, I'm as mystified as you. Do I need to take over the job of IR for this company? Maybe the data is still being assimilated for release, or maybe there's a bigger fish to fry. It's not even a question that the "new" data generated by the long-term Arikace study and presented at the international conference in Munich is PR-worthy, it's most likely legally required to release the data. And actually, they did, but not in a news release so far. Check out page 11 of the September investor's report and look at the highlighted area. This is new, unprecedented and positive clinical data supporting the long-term use of Arikace: "Interim Data from Open Label Extension Study Shows Continued Safety and Durability of Effect"
    Terry would argue that we had this info in the spring, but he would be wrong! In fact, that was preliminary, trending, but not conclusive, as this interim data shows.
    Then scroll to page 31, and look at the chart that demonstrates that longer-term data: 337 days in fact. Insmed is sitting on a geyser that's about to go! Sorry, that I have to be the one to PR this. Pretty crummy, huh?
    pianoman

    Sentiment: Strong Buy

  • jsblvbjb jsblvbjb Sep 9, 2014 1:56 PM Flag

    I thought Munich pres. was today. In any case, the Music will be done before Drechsler due to the time in Germany. I firmly expect this superiority to be PR'd in the morning, latest.
    pianoman

    Sentiment: Strong Buy

  • Reply to

    Sell today, kick yourself tomorrow...

    by jsblvbjb Sep 9, 2014 1:27 PM
    jsblvbjb jsblvbjb Sep 9, 2014 1:42 PM Flag

    Oh, ye of little faith. How could this stock not take off mightily with the results that Arikace just achieved? This is new, not old as Terry would claim. We only had preliminary data that was still inconclusive in the spring. It only pointed to this potential outcome. Why do you think Insmed scheduled this conference for the US tomorrow?
    pianoman

    Sentiment: Strong Buy

  • I'm not being overly-optimistic, nor am I making this up. I've reviewed the data from the Munich conference and Insmed will PR this data probably bright and early tomorrow morning: Arikace has demonstrated long-term beneficial and positive effect on lung function over 6 cycles of treatment. No other antibiotic regimen has even run a long-term trial to see, because in their short-term effective trials, there was still a degradation in lung function. THIS IS HUGE, and it's why the stock was up yesterday. Shorts are regrouping today because they think I was wrong. Guess again...
    pianoman

    Sentiment: Strong Buy

  • jsblvbjb by jsblvbjb Sep 9, 2014 9:12 AM Flag

    What happened to the bid/ask? This morning or tomorrow morning the news will be out, and the stock is going to spike IMO. Any other thoughts? BTW, I found the abstract on the Munich website that pointed to long-term positive effects of Arikace for NTM, which blows by Tobi's profile. This morning on CNN, Boomer's son Gunner was featured in his fight to survive CF. Former NFL QB has raised over 100 million to help find the cure and treatments for CF. Arikace would help folks like gunner right now, by simplifying daily antibiotic treatments from 2 to once a day and extended long-term FEV-1 improvements.
    pianoman

    Sentiment: Strong Buy

  • Reply to

    Nice 5% increase (14.69)

    by jd39souza98 Sep 8, 2014 4:20 PM
    jsblvbjb jsblvbjb Sep 8, 2014 5:27 PM Flag

    Someone knows something alright. I posted it on the YMB yesterday. About gave Terry a hernia when he read it! Heh, heh, heh... I didn't post the actual numbers from the abstract, just the conclusion, but buried in today's investor's presentation you can discern them from the 336 day chart. I expect Insmed will PR the awesome data either tomorrow morning or Wednesday morning preceding the Rodman and Renshaw conference.
    pianoman

    Sentiment: Strong Buy

  • jsblvbjb jsblvbjb Sep 7, 2014 2:15 PM Flag

    And now for the sneak-peak: drumroll please!

    Conclusion: These interim data demonstrate that LAI was well tolerated during 6 cycles, with AEs being consistent with those expected in a population of CF patients receiving inhaled medicines. Additionally, patients receiving 6 cycles of LAI showed mean increase in relative change in FEV1 that was sustained during both on- and off-treatment months, showing longer-term durability of treatment effect.

    Move over TOBI, there's a new gold standard in town!
    pianoman

    Sentiment: Strong Buy

  • If Arikayce shows long-term "superiority" over TOBI, then we're going to see a PR Tuesday morning followed by a really nice bounce.... Insmed wouldn't be giving an oral presentation for simply more of the same non-inferiority, now would they? Not IMO...

    Session 381: Oral Presentation: Cystic fibrosis: assessment and treatment
    Title: Interim data from a long-term safety, tolerability and efficacy study of liposomal amikacin for inhalation in cystic fibrosis patients with chronic Pseudomonas aeruginosa infection
    Day/Date: Tuesday, September 9, 2014
    Session Time: 10:45 a.m. - 12:45 p.m.
    Publication Page: OP3445
    Discussion: 11:15 a.m.
    Room: Room 5

    pianoman

    Sentiment: Strong Buy

  • Reply to

    Ice bucket challenge

    by jsblvbjb Aug 26, 2014 1:41 PM
    jsblvbjb jsblvbjb Sep 2, 2014 2:12 PM Flag

    I took the challenge and challenged the ALS to run an Iplex trial in partnership with some of the proceeds.
    From the ALSA webpage news release: “These funds will be used to fund cutting-edge research as well as care and support to people living with the disease,” said Newhouse. “Now and in the coming weeks, we will be able to enhance our strategic plan, reformulating and recasting strategies with input from stakeholders, including our donors, our chapters, and most importantly, people living with ALS and their families. We want to move quickly but decisively as our ultimate goal is to use this incredible generosity in a way that has the biggest impact on fighting this disease.”

    The video is on facebook, and I suppose you may have to be a "friend" to vew it, although my profile is probably open to the public, so possibly just find my profile.
    pianoman

    Sentiment: Strong Buy

  • Reply to

    Ice bucket challenge

    by jsblvbjb Aug 26, 2014 1:41 PM
    jsblvbjb jsblvbjb Aug 27, 2014 4:35 PM Flag

    Right on cue, Terry. Now I'm more convinced than ever this is the right thing to do. ALSA has raised 95 mill as of today! Cost of a phase 2 Iplex trial is in the 12 to 15 million dollar range. ALSA has never had this kind of funding before that I'm aware of, and their primary focus is finding an effective treatment for ALS. The time has arrived!
    pianoman

    Sentiment: Strong Buy

  • Reply to

    Latest short interest is UP.......

    by insmhistorian Aug 26, 2014 4:10 PM
    jsblvbjb jsblvbjb Aug 26, 2014 4:49 PM Flag

    I sincerely doubt that much or any of the secondary was bought by short hedges. A small percentage if any...
    pianoman

    Sentiment: Strong Buy

  • Reply to

    Ice bucket challenge

    by jsblvbjb Aug 26, 2014 1:41 PM
    jsblvbjb jsblvbjb Aug 26, 2014 2:30 PM Flag

    No worries! BTW, performed the Mark Hayes piano arrangement on Sunday.
    pianoman

    Sentiment: Strong Buy

  • This Wednesday evening I'm planning to take the Ice Bucket Challenge. My plan is to challenge ALSA to contact Insmed and help fund a phase 2 trial for Iplex with some of the massive funds raised due to this ridiculous practice of having ice water dumped on you. What do you guys think? Any suggestions? Thanks!
    pianoman

    Sentiment: Strong Buy

  • wait till you see the terms of an international marketing deal for Japan and beyond! I'm speculating 250 million at the least... Raising this 100+ million was just too easy, but considering the position Insmed is in with positive data packages and pending EU authorization in the near future, why should it be?
    pianoman

    Sentiment: Strong Buy

  • 109 million dollars is a lot of money! And that's what Wall Street understands, hence the 11% gain today. Soon enough, Insmed will make its move, and 30 bucks will be in the crosshairs. Buy now, for a large short term gain.
    pianoman

    Sentiment: Strong Buy

  • jsblvbjb jsblvbjb Aug 8, 2014 1:42 PM Flag

    Breakthrough allowed Insmed to advance Arikace into a rolling phase 3 trial, meaning that the FDA reserves the right to halt the trial and grant Insmed approval if the results come back similar to the successful phase 2. We had to go to phase 3 for the simple reason that Dr. Gupta failed to pick the correct primary endpoint, opting for a subjective proposition instead. FDA used breakthrough status to allow Insmed more accurate secondary endpoint to advance Arikace and to become the primary endpoint for this trial. All in all, it's a delay in the minds of all those that expected the FDA to grant approval based on the secondary endpoint, but in reality its a win for NTM patients that Insmed doesn't have to repeat a phase 2 as would have happened before breakthrough designation was created.
    pianoman

INSM
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