PAR 2.56% 20.0¢ paradigm biopharmaceuticals limited..

Ann: iPPS SIGNIFICANT OA PAIN REDUCTION AT 12 MONTHS, page-117

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    They already have 1.5mg/kg x 2 in the Stage 1 protocol.

    This may end up being replaced with 2mg/kg x 2 given safety concerns over rat studies has been comprehensively dealt with since.

    Remember the DMC will decide the final dosage protocol to be used for OA002 based on statistical significance of Stage 1 protocols. Interim results of Stage 1 are suggesting they will be accommodating to this request to revise the dosage protocols back to the preferred 2mg/kg. This optimal dosage is supported by all historical studies as being statistically significant with clinical meaningful effect size per (008, SAS, 2B, NFL etc). The chance of 2mg/kg x 2 not repeating the same or equivalent results are less than extremely remote. Those looking at the actual data will understand this point better than most of us on here.






 
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