PAR 2.27% 22.5¢ paradigm biopharmaceuticals limited..

Lets get this straight. Are you saying that 2mg/kgtwice weekly...

  1. 1,613 Posts.
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    Lets get this straight. Are you saying that 2mg/kg
    twice weekly was not included in the stage1
    dosing trial, because they were not confident
    of a statistically significant result for that particular
    dose and/or all doses?

    This was a 478 patient stage 1 trial and if 2mg/kg
    twice weekly had been included, then 478
    divided by 5 gives approx. 95 patients for each
    treatment arms plus placebo.

    If PAR was not confident of a favourable outcome
    from that size sample, then oh boy we are in
    potentially big trouble with the rest of 002 and
    003. What, where, when previous result would
    have shaken their confidence thus.

    And potential partners and FDA are not complete
    fools. If what you a suggesting is true, than there
    is a whiff of MSB trickiness about this.
 
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