To the best of my understanding, the P3 primary endpoint for...

To the best of my understanding, the P3 primary endpoint for Womac pain will have 2 components:

1. Clinically meaningful results - needs to be greater than the generally accepted industry standard of 25-30% reduction. Satisfying this should be a formality.

2. Statistically significant results - which means how you compare to placebo and proving that your outperformance of placebo was not by chance. This is achieved from a statistical standpoint by having the 95% confidence intervals not overlap. Looking at the Phase 2b results (n=112), we successfully demonstrated this at Week 8 (Week 53) despite the statistical power of this trial being limited. The greater the sample size the tighter the confidence intervals will be. Our OA002 and OA003 P3 trials will have much greater statistical power being n=938 and n=700, compared to n=112.


Additionally, I'd like to point out that the SAS results today were all measured at Week 12 (Day 81). PR previously mentioned that they will select Week 8 (Day 53) as the pre-determined date for measuring P3 success. If the Phase 2b results are anything to go by, the Week 8 results are likely to be much better than Week 12, all else being equal. Just look at the orange line above. Ie. If they are achieving 50% Womac pain reduction at Week 12, I'd be very surprised if we don't get 60%+ reduction at Week 8.