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