PAR paradigm biopharmaceuticals limited..

The P Value Primer, page-6

  1. 209 Posts.
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    Hi Mozz, I came up a question the other day when I review the clinic trial design of PARA_002. Appreciate if you or anyone else know the answers.

    In order to get FDA approved, do we need to meet all secondary endpoints of PARA_002? (there are 22 seconday endpoints, do we need to get statistically significant p<0.05 at all timepoints in the trial up to day168?)

    Or we only need to meet the key secondary endpoints (specfically it is function at day53, pain and function at day 84, p value <0.05)?

    https://hotcopper.com.au/data/attachments/5189/5189591-24065c0feb778057a064cfa1a6570d70.jpg

    https://clinicaltrials.gov/ct2/show/NCT04809376?term=pentosan&cntry=AU&draw=2&rank=2

 
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