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Insmed Incorporated Message Board

  • beachinv beachinv Jan 31, 2013 2:17 PM Flag

    Pharmaxis failure....

    This is why we are down - totally different drug platform not related to Arikace.... Their trials also failed some endpoints. Plus they had issues with kids coughing up blood....

    Time to buy more INSM...=)

    FDA reviewers question Bronchitol efficacy

    Published on Monday, January 28, 2013

    FDA reviewers said efficacy results for Bronchitol mannitol from Pharmaxis Ltd. (ASX:PXS; Pink:PXSLY) are "inconsistent," as the product met the primary endpoint in only one of two Phase III trials to manage cystic fibrosis (CF). Specifically, the reviewers concluded Bronchitol significantly improved the proportion of patients with an increase from baseline in forced expiratory volume in one second (FEV1) vs. placebo in Study CF302 -- but not Study CF301 -- based on an intent-to-treat (ITT) analysis. The comments came in briefing documents released ahead of Wednesday's Pulmonary-Allergy Drugs Advisory Committee meeting to discuss an NDA for the product.

    Pharmaxis proposed using a modified intent-to-treat (mITT) analysis that excluded patients who dropped out prior to week six, which it said showed Bronchitol met the primary endpoint in CF301 and approached significance in CF302 (p

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    • Yes look at our clinical trial data- it is much more impressive. Plus Amikacin is an approved drug. We are just a lipsomal formulation of Amikacin....

    • Again, this drug is not in the same ballpark as Arikace. Not in delivery or effectiveness of the drug itself. Only the sheeple who know nothing about the science and think they know how to invest sell in a panic. This is like saying that every early polio vaccine failed so therefore the Salk vaccine will fail.

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