email from ceo, page-11

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    some history from July 2012 merger report, re IV vs SC dosing:

    "Patients on the Trial were randomized to receive 75mg of XToll®, 25mg of XToll®
    or placebo via subcutaneous injections twice-weekly for 24 weeks. "

    "We note from Table 5.1 above that the primary endpoint of the Trial was not met as the difference
    in ACR20 mean values of the XToll® treated patient groups and the placebo treated patient groups
    was not statistically significant. The Trial did however show statistically significant or clinically
    meaningful improvement in a number of other measures of improvement, or secondary endpoints,
    in RA signs and symptoms."

    "The review suggested that subcutaneous dosing with XToll® in clinical trials has a low probability of
    meeting meaningful clinical endpoints and that further trials involving solely subcutaneous dosing
    should only be considered if a more suitable reformulated and/or reformatted form of XToll® is
    available. It was acknowledged that the time and money required to do this makes it more sensible
    to focus development of XToll® on alternative indications where the unmet need is such that
    relatively frequent dosing and/or intravenous dosing is acceptable to patients and physicians. "


 
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