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Insmed Incorporated Message Board

  • higgs_particle higgs_particle Dec 19, 2012 9:26 PM Flag

    You hear it first Insmed is going to drop the CF indication

    NTM only.They will say it is not worth the money.The US trial has already been cancelled

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    • I have tried to rebut this post 3 times now but Yahoo censors me. Who controls Yahoo?

      Sentiment: Strong Buy

    • On 11/20 they halted recruitment of TR02-108 and the trial went Active. Then just last week (12/11) the extension study of TR02-108 began recruitment. This means fully compliant participants in the TR02-108 trial have converted over to the extension study. If anything, this shows quick enrollment of the initial trial and a speedy enrollment into the extension. Yes, that sounds like the CF study was cancelled. And by the way...this is Canadian and UK.

      bwd

      • 3 Replies to biowatchdog
      • by rehdvm2004.Dec 22, 2012 2:09 PM.

        the Extension Trial commencement was announced on December 11, 2012 at ClinicalTrialsDOTgov, which is now policed by the FDA for accuracy. This is based upon only 28 days rest between Arikace treatment. Not the previously studied 56 days rest. The critical factor here is whether the shortened rest period gets rid of either more Pa or keeps the FEV1 up at a higher percentage improvement for longer.

        We shall see.

        Sentiment: Buy

      • "Primary Outcome Measures:
        •Incidence of treatment emergent adverse events [ Time Frame: Day 337 - first extension period ] [ Designated as safety issue: Yes ]

        •Treatment emergent adverse events including serious adverse events and adverse events leading to permanent discontinuation of study drug

        •Relative change in FEV1 [liters] and FEV1 % predicted [ Time Frame: Day 337 - first extension period ] [ Designated as safety issue: Yes ]

        •Acute tolerability as measured by PFT changes pre- to post-dose [ Time Frame: Day 337 - first extension period ] [ Designated as safety issue: Yes ]

        Secondary Outcome Measures:
        •Time to first protocol defined pulmonary exacerbation and proportion of subjects experiencing a protocol defined pulmonary exacerbation [ Time Frame: Day 337 - first extension period ] [ Designated as safety issue: Yes ]

        •Time to first antipseudomonal antibiotic treatment for protocol defined pulmonary exacerbation, proportion of subjects initiating treatment and number of days of treatment [ Time Frame: Day 337 - first extension period ] [ Designated as safety issue: Yes ]

        •Shift in minimum inhibitory concentration for Pseudomonas aeruginosa throughout the study [ Time Frame: Day 337 - first extension period ] [ Designated as safety issue: Yes ]

        •Evaluation of emergent pathogens [ Time Frame: Day 337 - first extension period ] [ Designated as safety issue: Yes ]"

        The primary criteria is breathing more easily (because of the liposome thinning the thick mucous) and the secondary criteria is killing Pa (antibiotic efficacy) for the additional time period. The dosage and frequency of administration remains the same for the additional treatment period.

        Only an emotionally unstable idiot would say I (or anyone else reading the same protocol) misread anything.

        Sentiment: Buy

      • F.O.S. The clinical trials network says you are a liar.The 6 month study has preliminary data in June and the study will be completed in August.Some of us celebrate the joy and truth of Christmas.

 
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