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Accelerated Approval for RECCE® 327, page-49

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    lightbulb Created with Sketch. 39
    Correct.
    From one of the patents:

    61]
    Successive generations of E. coli, S. aureus or P. aeruginosa respectively were cultivated via their selection through repeated exposure to a copolymer or Amoxicillin; Organisms surviving treatment were harvested for another cycle of treatment—this process being repeated up to 25 times.
    [0162]
    Both copolymers of Example 1 and Comparative Example 1 continued to achieve a normal reduction of approximately 102-103cfu/mL (or 99-99.9% of organisms) killed against up to 25 successive generations of E. coli, S. aureus and P. aeruginosa, respectively, and in each case, without any sign of increasing resistance to the anti-microbial activity of the copolymers; rates of antimicrobial kill of generation 1 and generations of their derived superbugs, when compared, were the same.
    [0163]
    This is considered to be a particularly demanding method of assessing the propensity of the bacteria to develop resistance to the antibiotic. If reduction of counts is a magnitude of 103 for each of 25 cycles—the resultant germ may be considered to be the most resistant by a selection of 1 in 1075.
    [0164]
    Parallel studies comparing similar treatments of E. coli and S. aureus, respectively with a 0.35% w/w solution of Amoxicillin antibiotic resulted in bacterial resistance after the second and eighth generation, respectively. The acrolein-copolymer product had normal antimicrobial rates against each of these generated “superbugs”.
 
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