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Aradigm Corporation Message Board

  • rehdvm2004 rehdvm2004 Jun 12, 2013 9:48 AM Flag

    Here is why ARDM will succeed . . .

    From the Phase IIb study:

    "Statistical significance was achieved in the primary endpoint - the mean change in Pseudomonas aeruginosa density in sputum (CFU) from baseline to day 28: there was a significant mean reduction of 4.2 log10 units in the Pulmaquin group, reflecting an almost sixteen-thousand fold decrease in bacterial load, versus a very small mean decrease of 0.1 log10 units in the placebo group (p=0.004)."

    Pseudomonas aeruginosa (Pa) is one of the fast mutating, antibiotic resistant organisms in respiratory infections. Virtually all persons with lung dysfunction are going to get infected multiple times because this organism is in potable water (drinking, showering, etc.);

    The data above indicate there was a 4.2 log reduction, pretreatment to Day 28 testing. One log is 10. Two logs is 100. Etc. So the data showed more than a 10,000 fold reduction in Pa bacteria in the patients treated. This level of bacterial reduction for Pa is very significant.

    Again, I am eagerly awaiting the announcement of the beginning of Phase III. The SP should jump appreciably at that time.

    GLTAL

    Sentiment: Strong Buy

 
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