I recall PR saying something to the effect of "1.5 mg/kg had the same pharmacokinetic profile to 2.0 mg/kg so it should have the same impact on pain and function". I'm hopeful that the large sample size will see us achieve the primary endpoint using the 1.5 mg/kg dosage (117 in stage 1 and an additional 235 in stage 2 ), but it is good to see that 2.0 mg/kg will be considered for stage 2 if the DMC decide to terminate the trial due to underwhelming efficacy. We should find out at the end of stage 1 when the DMC evaluate the primary endpoint and key secondaries; pain and function at days 58 and 84. As of today it appears they've only conducted two safety reviews.
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- Ann: PAR Reports Phase 3 Clinical Trial Update
Ann: PAR Reports Phase 3 Clinical Trial Update, page-34
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