This is what it says...
Clinical trial met the primary endpoint - change in the KOOS pain from baseline at Day 53 for the total trial population (p < 0.0001);
• Mean Change in KOOS Pain from Baseline – Total Population. Clinically meaningful and statistically significant results – see chart 1 below;
• Mean Change in KOOS Pain from Baseline – NRS:4-6 Strata. Clinically meaningful and statistically significant results – see chart 2 below;
• Mean Percentage Change in NRS Pain from Baseline – NRS:4-6 Strata. Clinically meaningful and statistically significant results (p<0.028) – see chart 3 below;
• Number of subjects with a >50% Reduction from Baseline in KOOS Pain Score at Day 53 – NRS:4-6 Strata. Clinically meaningful and statistically significant results (p<0.026) - see chart 4 below;
• Number of subjects with a >50% Reduction from Baseline in KOOS Pain Score at Days 11-81 – NRS:4-6 Strata. Clinically meaningful and statistically significant results (p<0.021) - see chart 5 below;
• Number of subjects with a >50% Reduction from Baseline in NRS Pain Score at Days 11-81 – NRS:4-6 Strata. Clinically meaningful and statistically significant results (p<0.02) - see chart 6 below;
• A key measure in pain outcomes is the Patient Global Impression of Change1 (PGIC) the total population and placebo was statistically (PGIC, p=0.0062);
• All secondary endpoints will be reported on Q1/Q2 CY2019;
• All data will be the subject of a peer-review publication in CY2019;
• Safety of drug confirmed; and
• Paradigm believes there is a high probability that the drug will be successful in a Phase 3 clinical trial and therefore will have big pharma licensing/partnering interest.
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- Ann: Paradigms Supplementary Phase 2B Data
Ann: Paradigms Supplementary Phase 2B Data, page-14
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