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Insmed Incorporated Message Board

underdogs14 24 posts  |  Last Activity: Jun 28, 2016 6:12 PM Member since: Aug 10, 2007
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  • Reply to

    BIZARRE EMA?

    by underdogs14 Jun 28, 2016 6:07 PM
    underdogs14 underdogs14 Jun 28, 2016 6:12 PM Flag

    Maybe the current FDA phase lll trial using only MAC patients converting at say 70% will convince them? Amazing.

    Sentiment: Buy

  • underdogs14 by underdogs14 Jun 28, 2016 6:07 PM Flag

    The EMEA was not prepared to recommend approval, since there was not enough evidence that Arikayce can 'permanently' clear the bactueria from the sputum (what drug can even convert?), and thus the “benefits of Arikayce did not outewiegh its risks” (what risks?)

    So 30% safe,culture conversion on drug within 6 months and 80% of those still converted and safe after 1 year of non use while no drug has been approved for a lethal disease is not good enough for a The EMA? Just BIZARRE

    http://www.ema.europa.eu/docs/en_GB/document_library/Medicine_QA/2016/06/WC500209287.pdf

    Sentiment: Buy

  • Reply to

    New patent/Platinum cancer treatment

    by underdogs14 Jun 23, 2016 10:43 AM
    underdogs14 underdogs14 Jun 23, 2016 10:49 AM Flag

    The Eleison license doesn’t pertain to liposomal cisplatin for injection into the body cavity, targeting cancers beyond the lung; hence the new patent application.

    Sentiment: Buy

  • Reply to

    New patent/Platinum cancer treatment

    by underdogs14 Jun 23, 2016 10:43 AM
    underdogs14 underdogs14 Jun 23, 2016 10:46 AM Flag

    Insmed previously granted Eleison a license to develop liposomal cisplatin for inhalation:

    Inhaled Lipid-complexed Cisplatin (ILC)

    Eleison has an exclusive worldwide license to ILC, a novel, sustained release formulation of cisplatin in a nanoscale lipid based complex administered via inhalation, in development for pediatric osteosarcoma (OS) - bone cancer. ILC was designed to deliver high levels of sustained release cisplatin targeted to the lung, without systemic-related toxicities. ILC has been evaluated in 89 patients in four clinical studies, with evidence of efficacy in several cancer types including lung and bronchoalveolar.

    In pediatric OS, approximately 35% of patients fail first-line therapy, mostly with metastatic recurrence only in the lungs, and with poor prognosis (five year survival of such patients is

  • New patent application filed last week.
    Platinum for cancer treatment, encased in liposomes, and injected into the body cavity to bypass the gastric tract.

    Abstract
    One aspect of the invention relates to methods of treating cancer in a patient comprising administering intraperitoneally to a patient in need thereof a cancer treating effective amount of a composition comprising a lipid-complexed platinum compound wherein the concentration of the platinum compound of the lipid-complexed platinum compound composition is greater than about 1.2 mg/ml. Another aspect of the invention relates to lipid-complexed platinum compound compositions where the concentration of the platinum compound is greater than about 1.2 mg/ml.

    Sentiment: Buy

  • underdogs14 underdogs14 Jun 20, 2016 10:11 AM Flag

    Good points pianoman. Credit to Hound-dog..,

    At clinical trials.gov, a study conducted by University of Miami and University of Florida:

    “To determine the prevalence of nontuberculous mycobacterial infection (NTM) in pediatric patients with cystic fibrosis in the State of Florida. HYPOTHESIS: There is high prevalence of NTM in CF pediatric population in the State of Florida, and likely higher than in the rest of the country.”

    Sponsor:
    University of Miami
    Collaborator:
    University of Florida
    Information provided by (Responsible Party):
    Andrew Colin, University of Miami

    Study completed; results not yet posted.

    https://clinicaltrials.gov/ct2/show/NCT02198079?term=ntm&rank=6

    Sentiment: Buy

  • Reply to

    Strange??

    by underdogs14 Jun 11, 2016 6:43 PM
    underdogs14 underdogs14 Jun 14, 2016 11:01 AM Flag

    Insmed may be closer to FDA approval than anyone realizes.

  • underdogs14 by underdogs14 Jun 11, 2016 6:43 PM Flag

    Somethings in the works..,
    Next week’s COMP meeting:

    4.2. Orphan designated products for discussion prior to adoption of CHMP opinion

    4.2.3. - amikacin –EMA/OD/024/06, EU/3/06/387, EMEA/H/C/003936
    Insmed Limited;
    a) Treatment of Pseudomonas aeruginosa lung infection in cystic fibrosis (EMA/OD/024/06, EU/3/06/387)
    b) Treatment of nontuberculous mycobacterial lung disease (EMA/OD/191/13, EU/3/14/1259)
    Action: For discussion
    Document(s) tabled:
    Draft report on review of OMPD

    If they weren’t in line for a Conditional Approval - - if the CHMP was going to reject them outright, why would this be on the COMP Agenda?
    Also why the reference to CF?

    Sentiment: Strong Buy

  • underdogs14 underdogs14 Jun 2, 2016 11:04 AM Flag

    Going way higher.., indeed

    Sentiment: Strong Buy

  • Reply to

    From the EMA...

    by jsblvbjb May 25, 2016 4:00 PM
    underdogs14 underdogs14 May 25, 2016 4:10 PM Flag

    Yes Jess, I see pre AUTHORIZATION noted, but the EMA has already allowed the use in 3 countries in a compassionate use authorization and didn't Mr. Lewis purchase over 1/2 million dollars worth of stock just a few short months ago at $13+. We are golden.

    Sentiment: Strong Buy

  • Reply to

    New patent

    by underdogs14 May 23, 2016 5:03 PM
    underdogs14 underdogs14 May 23, 2016 5:05 PM Flag

    This is the project where they will administer an approved antibiotic (Vancomycin) via their liposomal therapy, to treat MRSA.

    United States Patent Application 20150314002
    Kind Code A1
    Perkins; Walter ; et al. November 5, 2015
    ________________________________________
    STABILIZED VANCOMYCIN FORMULATIONS
    Abstract
    In one aspect, the invention provides a stabilized lipid-based glycopeptide antibiotic composition and a process for producing the same. In another aspect, the invention provides methods for treating a bacterial pulmonary infection by administering to a subject in need thereof a therapeutically effective amount of the stabilized lipid-based glycopeptide antibiotic composition.

    Thanks HoundDogs

    Sentiment: Strong Buy

  • underdogs14 by underdogs14 May 23, 2016 5:03 PM Flag

    United States Patent 9,333,214
    Gupta May 10, 2016
    ________________________________________
    Method for treating pulmonary disorders with liposomal amikacin formulations
    Abstract
    Disclosed herein are methods of treating pulmonary disorders comprising administering to the patient an effective dose of a nebulized liposomal amikacin formulation for at least one treatment cycle, wherein: the treatment cycle comprises an administration period of 15 to 75 days, followed by an off period of 15 to 75 days; and the effective dose comprises 100 to 2500 mg of amikacin daily during the administration period.

    Sentiment: Strong Buy

  • Reply to

    How is it even possible???

    by jsblvbjb May 23, 2016 10:21 AM
    underdogs14 underdogs14 May 23, 2016 10:30 AM Flag

    Jess, you are way too lite on your target. The reward is coming full stream.

    Sentiment: Strong Buy

  • Reply to

    Holdings Summary

    by iounothjing1 May 20, 2016 8:12 PM
    underdogs14 underdogs14 May 21, 2016 7:41 AM Flag

    I purchased 1,360 last week. Trying to buy more. Can't believe it's this low.

    Sentiment: Strong Buy

  • Reply to

    CHMP Meeting is this Monday, May 23

    by blasedp31 May 18, 2016 8:48 AM
    underdogs14 underdogs14 May 20, 2016 4:00 PM Flag

    Wouldn't it be something if we were on the CHMP agenda next week?

    Sentiment: Strong Buy

  • Reply to

    Biowatchdog - invitation to an oral hearing

    by arikaycerocks Feb 19, 2016 3:22 PM
    underdogs14 underdogs14 May 16, 2016 10:57 AM Flag

    In the B of A conference call I believe I heard that the convert study includes most all MAC abs patients. Could you imagine what those results will do to our stock price?

  • Reply to

    EMA approval

    by dhowe80227 May 12, 2016 4:05 PM
    underdogs14 underdogs14 May 12, 2016 5:11 PM Flag

    Compassionate use in 3 countries now is precursor for approval. Delay due to label but expected mid year '16. France paying $60k per year. Said today $50k to $100k per year in USA. I believe $30+ with Europe approval and beyond. Trying to buy more. Huge upside

    Sentiment: Buy

  • Reply to

    Question for each of you

    by donetesme May 11, 2016 1:58 PM
    underdogs14 underdogs14 May 11, 2016 3:37 PM Flag

    I am happy to have a very good amount of INSM and for about 10 months now buying more and more of TROV. Inv co l follow specked on trove and I followed. Love the science if they can get the strong management needed.

  • Conclusion: Twelve-month follow-up data describing durability of treatment suggests for many patients achieving culture conversion after 3-6 months of add-on LAI treatment, sputum remains negative up to 12 months after LAI is discontinued. Study findings continue to support the potential role of LAI as a viable add-on treatment to standard multi-drug regimens for NTM lung infections in patients refractory to previous multi-drug regimens.

    Sentiment: Strong Buy

  • Reply to

    There's a math problem...

    by jsblvbjb May 4, 2016 9:42 AM
    underdogs14 underdogs14 May 4, 2016 10:42 AM Flag

    This stock will explode higher very soon..,

    Those who fill these boards with fear are trying to steal your shares.

    Arikayce, IPLEX, INS1009, Bp3, Inhaled Lipid Cisplaton, MRSA, IPF and Sarcoidosis

    Now adding severe refractory asthma.

    Sentiment: Strong Buy

INSM
11.4392+0.1092(+0.96%)12:11 PMEDT