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Insmed Incorporated Message Board

  • rehdvm2004 rehdvm2004 Jun 1, 2013 9:15 AM Flag

    The NIH clinical trial protocol is much more detailed than the one at ClinicalTrials . . .

    A Randomized, Double-Blind, Placebo Controlled Study of Liposomal Amikacin for Inhalation (Arikace(Registered Trademark)) in Patients with Recalcitrant Nontuberculous mycobacterial Lung Disease

    Eligibility - Inclusion (6 on CTg v. 10 on NIH trial):

    3. History of chronic infection defined as at least 2 documented positive cultures in the prior 2 years, of which at least one was obtained in the 6 months prior to screening with either Mycobacterium avium complex or Mycobacterium abscessus or mixed infection with both species (NTM contaminants M. gordonae, M. haemophilum, M. mucogenicum, M. nonchromogenicum, and M. terrae complex are allowed as long as MAC and/or M. abscessus are the predominant organism). The cultures could have been obtained from sputum or bronchoscopy.

    4. Positive sputum culture obtained during the screening period with either Mycobacterium avium complex or Mycobacterium abscessus or mixed infection with one dominant species.

    Exclusion (12 on CTg v. 27 on NIH clinical trial):

    9. History of acute pulmonary exacerbation requiring treatment with antibiotics within 4 weeks prior to screening or anytime during screening.

    12. Initiation of chronic therapy (e.g., high-dose ibuprofen, inhaled anti-inflammatory agents including steroids, low dose maintenance steroids, rhDNase, chronic suppressive antibacterial treatment) within the 28 days prior to screening.

    14. Prior exposure to Arikace (including clinical study).

    16. Use of inhaled antibiotics, systemic aminoglycosides (e.g., tobramycin, amikacin, gentamicin or streptomycin) from the screening visit through Study Day 1 (including at least 28 days prior to Study Day 1).

    It is called "shorting the truth" for purposes of manipulating the information. Spumpers will never change. They should have a penalty for holding a stock less than 3 month like they do with mutual funds. Then this shorting and manipulation business would become limited because of lack of "validation."

    Sentiment: Strong Buy

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    • Again . . . NIH website, clinical trials and the name of the trial should get you half way there. But if you are not big on OPT, go pick your own cherrys and complete your own DD.

      Sentiment: Strong Buy

    • Government action is not needed for one to spot the true manipulators.

      I like how you cherry-picked the criteria you chose to post.

      You forgot this from exclusions:

      17. Any change in chronic NTM multi-drug regimen within 28 days prior to Study Day 1.

      And this from inclusions:

      5. Receiving ATS/IDSA guidelines-based treatment regimen defined as: adherent to a multi-drug regimen for at least 6 months prior to screening with persistently positive mycobacterial cultures.

      Again, I don't know if this is about "the big three" that was mentioned in my "NTM forum" post that started you on your little tirade, but I see no reason to exclude this information.

      Your style has always been the same. A poster asks what 2+2 equals or states that 2+2=4 and you fire off a large list of complex equations that have little to do with the original post and then you complain about "spumpers" and manipulators."

      Truly boring.

      Sentiment: Strong Buy

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