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Insmed Incorporated Message Board

jsblvbjb 372 posts  |  Last Activity: Apr 16, 2014 8:19 AM Member since: Jan 19, 1999
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  • jsblvbjb by jsblvbjb Apr 16, 2014 8:19 AM Flag

    Remember the financial crisis of 2008? Insmed had failed MMD trial and our money was nearly exhausted. Then suddenly....
    You don't remember?
    Allan waived his hand and 130 million from Merck was created. Well, it was a bit more involved than that, but the point is our current CEO is in a much stronger position and despite this market crisis, the next deal will be a cash partnership for NTM worldwide which could outdo even the Merck deal from 2008. This deal is independent of the market price manipulation accomplished by our greedy biotech short hedgies. Their time is coming, and yesterday they overshot their target, neutering their ability to drive the price down any further today or tomorrow. So, buck up, buy shares and be patient as Lewis negotiates a stellar deal and with a foreign entity and the FDA. The larger the short position, the worse they will have it when the news breaks!
    pianoman

    Sentiment: Strong Buy

  • Reply to

    EC Orphan Designation

    by biowatchdog Apr 16, 2014 8:06 AM
    jsblvbjb jsblvbjb Apr 16, 2014 8:10 AM Flag

    yup...
    pianoman

    Sentiment: Strong Buy

  • Reply to

    CEO's presentation on 4/9

    by sigma_capitals Apr 11, 2014 7:38 PM
    jsblvbjb jsblvbjb Apr 13, 2014 2:49 PM Flag

    Yes on number 1, not sure on number 2 because all patients in second phase of trial are on Arikace, and therefore cannot be compared to placebo arm. It could be a yes, though!
    pianoman

    Sentiment: Strong Buy

  • jsblvbjb by jsblvbjb Apr 10, 2014 3:19 PM Flag

    Bottom of the double bottom is now...
    Watch for a V shaped recovery!
    pianoman

    Sentiment: Strong Buy

  • Reply to

    Jad, any thoughts now on Wednesday's trading?

    by fudfighter4 Apr 9, 2014 6:08 PM
    jsblvbjb jsblvbjb Apr 9, 2014 8:42 PM Flag

    fud, WL stated at Needham that Insmed was fully funded for commercial launch. Did you miss that detail?
    pianoman

    Sentiment: Strong Buy

  • Reply to

    Cost of study

    by justarook04 Apr 9, 2014 8:35 AM
    jsblvbjb jsblvbjb Apr 9, 2014 4:43 PM Flag

    Not dogs, micheal, two mice! FDA required the dogs as a result. But Rehd is full of garbage today, and I don't even have the time to debunk him, his argument is so full of holes!
    pianoman

    Sentiment: Strong Buy

  • Reply to

    FDA discussions will include . . .

    by rehdvm2004 Apr 9, 2014 12:24 PM
    jsblvbjb jsblvbjb Apr 9, 2014 12:31 PM Flag

    rehd, you are full of it. No one believes you anymore. And you're conclusions are totally wrong about the clinical results, as well..
    pianoman

    Sentiment: Strong Buy

  • Right at the end of the call: Partners pursuing Insmed, NTM results changes the equation for Insmed. Worldwide plans will be in place by end of 2nd quarter!
    pianoman

    Sentiment: Strong Buy

  • They wanted to see "culture conversion!" Lewis had this discussion with the FDA already.

    Sentiment: Strong Buy

  • 3 month study will occur with or without approval as phase 3 or phase 4. 2015 launch with phase 4, 2016 with phase 3.
    pianoman

    Sentiment: Strong Buy

  • Reply to

    On the call...

    by jsblvbjb Apr 9, 2014 8:18 AM
    jsblvbjb jsblvbjb Apr 9, 2014 8:21 AM Flag

    Lewis believes we have the data to support approval in both NTM and CF.
    pianoman

    Sentiment: Strong Buy

  • jsblvbjb by jsblvbjb Apr 9, 2014 8:18 AM Flag

    NTM negative culture results both "compelling" and "shocking." Primary endpoint not the main takeaway, but was skewed by unrelated-to-drug patient death and patient missing sample date, etc. Purpose of primary was to "predict" secondary endpoint, since the secondary was not expected to be achieved! And it was!

    CF long term results "encouraging." First and only once-daily treatment (that's gotta have some competitors quaking in their boots).

    Hoping to file for NTM approval this year in US, will find out from FDA this quarter if it's a go...
    Will continue trials with NTM even with approval pathway.

    Sentiment: Strong Buy

  • Dr. Gupta received an offer she couldn't refuse! After the "success" of NTM and CF in such a short period of time, someone with deep pockets offered her a major new position with the caveat that she could remain as an advisor to Mr. Lewis. No one gets dismissed and then gets to remain on board as an advisor. Insmed is fortunate that Dr. Gupta continues to advise! We are full steam ahead with both NTM and CF, and now that a double-bottom has formed (or is forming), the stock is setting up for a major break-out, IMO.
    pianoman

    Sentiment: Strong Buy

  • They picked the wrong side of the trade! Go Insmed!
    pianoman

    Sentiment: Strong Buy

  • IMO, Will is looking for a CMO with better communication skills. Now that Gupta is done taking Arikace through clinicals there's not so much left for her to do. The new CMO will be designing trials for "new" products it would appear! What could that be? Something out of Gupta's expertise perhaps?
    pianoman

    Sentiment: Strong Buy

  • Reply to

    Terry. topic deleted ROFLMAO! Is this why?

    by terry_insm Apr 2, 2014 10:07 AM
    jsblvbjb jsblvbjb Apr 2, 2014 11:36 AM Flag

    Terry, you were quite fortunate to make money off your short position after the news. I suspect many shorts did not cover, thinking the news was a death-warrant for INSM. I'm glad you recognized the "cures" as you call them, and went long just in time for this current leg up. I'm expecting buy-out rumors to start driving the share price, now that Arikayce has proven to treat efficaciously the most difficult NTM patients to cure.
    pianoman

    Sentiment: Strong Buy

  • When will this guy ever learn? Can you see the glaring flaw in this article?

    Wedbush reiterated an Underperform rating on Insmed (NASDAQ: INSM) price with a target of $7.00. Comments follow infectious disease physician checks.

    "Following the announcement of top-line data from the Phase II ARIKAYCE study in the treatment-resistant nontuberculous mycobacteria (NTM) setting last week, we spoke to several infectious disease specialists about the results," said analyst Gregory R. Wade. "Although each was enthusiastic and encouraged by the report of sputum culture conversion, each also indicted that any real change in the bacterial burden in the lung would be expected to be accompanied by a similar clinical improvement. One suggested that additional measures to confirm culture conversion and improvement in NTM bacterial burden in the lower airways could include bronchio-alveolar lavage and quantitative PCR."

    "We believe there are 2 potential scenarios for the Phase II efficacy of ARIKAYCE in the NTM setting. 1. Concordant clinical improvement will be reported at ATS for patients with culture conversion or improvement sputum density. We would expect FDA to be potentially receptive to a regulatory filing in this scenario. 2. There is little or weak evidence of concordant improvement in clinical features in patients with culture conversion or improvement in sputum density presented at ATS. This data would suggest to us that the microbiological measures are possibly misleading or occur ahead of potential clinical improvement that would be expected if there is a real reduction in NTM bacteria in the lungs. We would not expect the FDA to be receptive to a regulatory filing in this case," he added.

    For an analyst ratings summary and ratings history on Insmed click here. For more ratings news on Insmed click here.

    Sentiment: Strong Buy

  • Imagine with all the carnage in biotech over the past couple of week, if Insmed had released sour data. Our stock would've been smoked lower! Instead, the price targets have been raised by 2 analysts, others have upheld their targets, and Wedbush is going to have to revisit their 7 dollar target, since his rationale was punted out the window by Insmed's Arikayce success! I truly believe Insmed is now the number 1 buy-out candidate in the world, and 45 dollars is my target price on the rumor, when it starts.
    pianoman

    Sentiment: Strong Buy

  • Insmed Update
    INSM : NASDAQ : US$15.91
    BUY 
    Target: US$30.00
    COMPANY DESCRIPTION:
    Insmed is focused on developing novel, targeted inhaled
    therapies for the treatment of serious orphan lung diseases. Its
    lead product candidate is Arikace, a liposomal formulation of FDA
    approved antibiotic, amikacin.
    All amounts in US$ unless otherwise noted.
    Life Sciences — Biotechnology
    DATA ANALYSIS ARBITRAGE:
    TOTALITY OF NTM DATA SUPPORTS
    ACTIVITY, SAFETY AND APPROVAL
    Investment recommendation
    Reiterate BUY, $30 PT on Arikace’s potential in nontuberculous
    mycobacteria (NTM).
    INSM’s lead drug Arikace is an inhaled liposomal form of FDA-approved amikacin. We view the Ph2 US NTM data as clearly positive, and culture conversion/safety data as supportive of expedited approval. Our $30 target is based on a pNPV analysis.
    Investment highlights
     We see a clear, and likely abbreviated path to approval strongly
    supported by culture conversion and QoL data. We think six-month
    extension culture conversion, conversion over time, and QoL data to
    be presented May 20th at ATS (San Diego) will support a subpart H
    filing, a positive AdComm and conditional approval, given what we
    see as strong clinically meaningful data in an unmet need.
     Primary endpoint statistics confounded by small numbers, unrelated
    death. The sensitivity of the primary endpoint Wilcox rank sum
    analysis is underscored by the change in p-value from p=0.148 to
    p=0.02 when a repeated measures analysis is conducted excluding
    the unrelated patient death. We think FDA’s previous strong focus
    on cures/QoL (supported by our talks with KOLs) hasn’t changed.
     QDIP/GAIN gives FDA the flexibility to focus on the drug’s activity:
    we think breakthrough status is highly likely. While some investors
    are focused on safety, we think the lack of renal and ototoxicity and
    note FDA has approved antibiotics for unmet needs with much more
    problematic safety profiles

    Sentiment: Strong Buy

  • You could hear it in his voice this morning. The doctors were "impressed and excited" by the clinical outcome. They testified to unexpected efficacy. Folk, the analysts found assurance based on the doctors testimony: (from IBD article)
    "Although Arikayce did not show significance on the primary endpoint of bacterial reduction, we believe this is a less validated and sensitive measure and that success on the more stringent secondary endpoint of culture conversion to negative derisks the program significantly," wrote Leerink Swann analyst Joseph Schwartz in a research note. "We have previously assumed a 60% probability of accelerated approval, 20% probability of approval after another Phase III trial, and a 20% probability of outright failure. The latter downside scenario has been removed, in our view."
    Schwartz lifted his price target on Insmed stock to 30 from 22. The stock was trading near 16 midday Wednesday, a three-month low.
    Piper Jaffray analyst Joshua Schimmer also said the secondary endpoint was "much more meaningful and clinically relevant," and he reiterated his overweight rating.

    What more do we need? Over the long-term, Arikace tends to cause further improvements as proven by the CF trial extension, and the direction of the current NTM trial. The drop today is consistent with past-positive PRs concerning Arikace, which proceeded big upswings. We have a winner!
    pianoman

    Sentiment: Strong Buy

INSM
13.41+0.88(+7.02%)Apr 17 4:00 PMEDT

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