Par002: Dosing study will be about 12 months. Exact timing depends on speed of patient recruitment. Numbers are Placebo 117n: 2*Wk Kg 117n : 1*Wk Kg 117n : 1*Wk Fix 117n. So number of patients in this 4 arm controlled study will be greater with the phase 2b study. The criteria for inclusion in trail will be stricter than the phase 2b trail so the known very high placebo influence on stage 4 OA patients is reduced. The results of these arms will give a statistically powered outcome for the success of follow on studies.
Par008: DMOAD primary endpoints and pain function etc secondary endpoints. Read Q3 CY2022. I suspect we will see further patent IP protection being placed on novel mechanisms of action for DMOAD discovered from the first 30 patients that are now past day 56.
So with these 2 studies completed, one will have a good idea if the product works as in the prior phase 2b/SAS studies and if we have a blockbuster.
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