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Insmed Incorporated Message Board

jsblvbjb 7466 posts  |  Last Activity: Aug 14, 2014 4:03 PM Member since: Jan 19, 1999
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  • 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

  • Of course, if we go PUMA on "unexpected" CF results (remember the preliminary data that pointed to superiority over TOBI?) or FDA guidance to gain approval based on Phase 2 for NTM (telegraphed by the BTD) then you guys can have my shoulder to cry on...
    God bless,
    pianoman

    Sentiment: Buy

  • What direction is the FDA going to sign-off on? How soon l it be before Insmed has officially applied for NTM approval in the EU? What does Insmed have up its sleeve concerning Iplex? Abbvie valued Premiplex at a billion for the buyout it would appear based on the analysts comments. When does Insmed blow the the top off the SP with one easy stroke? If I were a short, I would be super nervous!
    pianoman

    Sentiment: Strong Buy

  • jsblvbjb by jsblvbjb Jul 18, 2014 2:32 PM Flag

    AbbVie will gain a series of rare disease drugs, including Elaprase for Hunter syndrome, a genetic disorder, and Replagal, to treat Fabry disease. It also inherits experimental products, including lifitegrast for dry eye, and Premiplex for a potentially blinding eye disorder in infants. Premiplex could generate more than $1 billion annually if it reaches the market, said Jason Gerberry, an analyst at Leerink Partners.

    Wow! Where have we heard of this one?
    pianoman

    Sentiment: Strong Buy

  • into what's coming for them! Heh, heh, heh....
    BTW we welcomed our 3rd this past week. A beautiful little baby girl and she is sweet as can be.
    pianoman

    Sentiment: Strong Buy

  • Reply to

    To quote the late great Paul Harvey...

    by jsblvbjb Jun 16, 2014 10:17 AM
    jsblvbjb jsblvbjb Jun 18, 2014 4:58 PM Flag

    And there you have it!
    pianoman

    Sentiment: Strong Buy

  • jsblvbjb jsblvbjb Jun 18, 2014 4:58 PM Flag

    The answer to your question is "probably" not. But they will run an expansion trial nonetheless, likely a phase 4. Insmed now has authority to pursue approval based on Phase 2 data via this Breakthrough designation. The completed NTM trial was designed as a phase 3 in the first place.
    pianoman

    Sentiment: Strong Buy

  • Reply to

    Shh

    by biowatchdog Jun 18, 2014 11:00 AM
    jsblvbjb jsblvbjb Jun 18, 2014 4:56 PM Flag

    I was speaking with underdogs earlier today, and my idea was a "perfectly" wrapped gift for the shorts on an inconspicuous Wednesday morning would be an SEC filing with no headline that posts to the business news on Yahoo! and Marketwatch. Every short in the world was licking their chops when they clicked the link, and then they lost their previous evening's dinner! #$%$...
    pianoman

    Sentiment: Strong Buy

  • "Stand by for news." This week? or next...
    Don't be shocked by a tremendous reaction to the upside. Terry's already working overtime to dampen any potential enthusiasm. He will fail this time!
    pianoman

    Sentiment: Strong Buy

  • Reply to

    Where is Pianoman lately? BWD? FUD?

    by justarook04 Jun 11, 2014 6:36 PM
    jsblvbjb jsblvbjb Jun 12, 2014 2:16 PM Flag

    Right on, oji! I'm here and maintaining the strong buy!
    pianoman

    Sentiment: Strong Buy

  • Reply to

    Phenomenal acquisition to the BOD...

    by jsblvbjb May 29, 2014 9:48 AM
    jsblvbjb jsblvbjb May 29, 2014 9:57 AM Flag

    I think the AZN spec does have legs, but why settle for a buyout, when you can get to the promised land based on your own merit? I think you can figure out what a done deal is if I'm not referring to a buyout.
    pianoman

    Sentiment: Strong Buy

  • I was wondering if anyone noticed. Insmed has 50 in the crosshairs, near term. Done deal... Any questions?
    pianoman

    Sentiment: Strong Buy

  • Wall Street has no clue what that means. How about long-term safety and clinical benefit for CF patients in the extension study, with 91% reenrollment? There was no PR, so as far as WS knows, a tree fell in the forest! Meanwhile, Wade dropped his coverage of Insmed, because he actually read the data and panicked. Wouldn't you have, if you had a 7 dollar price target in the face of FDA approval, EU approval, Japanese partnership and a gateway to a host of indications swinging open? So Insmed is in the sweet spot, although the price doesn't reflect it. Institutions are locked and loaded, while a few scragglers are positioning for the last few shares available. Today is the day the "big news" is released, and Insmed doesn't even have to PR it. Check their website, watch the webcast, be informed, be smart, be invested for a 10 bagger!
    pianoman

    Sentiment: Strong Buy

  • Reply to

    Wade's folly...

    by jsblvbjb May 18, 2014 3:11 PM
    jsblvbjb jsblvbjb May 18, 2014 4:57 PM Flag

    What's the matter, Terry, did Gregory hang your shorts out to dry this weekend? How many others actually took him seriously? He was a farce!
    pianoman

    Sentiment: Strong Buy

  • jsblvbjb by jsblvbjb May 18, 2014 3:11 PM Flag

    cost his investors big time! News is out, and it's on the website currently. I do expect a PR Monday morning! Off to the races at that time...
    pianoman

    Sentiment: Strong Buy

  • [10:30 AM] Interim Analysis Of A Long-Term, Open-Label Safety, Tolerability, And Efficacy Study Of Liposomal Amikacin For Inhalation In Cystic Fibrosis Patients With Chronic Infection Due To Pseudomonas Aeruginosa, [Publication Page: A6571]
    Results: A total of 268 patients completed CLEAR-108, of which 206 (77%) were enrolled in CLEAR-110. The percentages of patients distributed according to age strata were: 6-12 years (21.8%), 12-18 years (27.7%), and 18 years (50.5%). The distribution of percentages of patients according to FEV1 % predicted strata was similar: 25-50% (30.6%), 50-75% (34.4%), and 75% (35.0%). All patients enrolled in CLEAR-110 have received at least 1 dose of LAI; of these, 92 patients received LAI in CLEAR-108 and 114 received TIS. As of December 31, 121 of 133 (91.0%) patients who have completed the first extension have consented to participate in the second extension. Analysis of safety data for patients who have completed week 48 will be available in the first quarter of 2014.

    Sentiment: Strong Buy

  • jsblvbjb jsblvbjb May 18, 2014 9:51 AM Flag

    Wow! Greg Wade blinked! This week is going to be awesome,,,
    Praise the Lord on His day...
    pianoman

    Sentiment: Strong Buy

  • Reply to

    According to Etrade Institutional Holdings

    by justarook04 May 14, 2014 8:21 AM
    jsblvbjb jsblvbjb May 14, 2014 8:48 PM Flag

    Remember NFLD. That one gave me a bad feeling, so I wouldn't have touched it with a 10 foot pole. I'm glad you survived to fight another day!
    pianoman

    Sentiment: Strong Buy

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