You will need to meet pain and function at day 56, so you need...

You will need to meet pain and function at day 56, so you need to hit the primary endpoint and the first key secondary. Key secondary endpoints are important to achieve and in some cases can be considered similarly to the primary endpoint, so it is interesting to see that two key secondary endpoints are pain and function at day 84 as well.

PR mentioned previously that FDA wanted pain as primary endpoint, but EMA wanted function, so they have included both essentially as a primary endpoint. I assume function is a key secondary due to potential multiplicity effects and type I error rate.

Looking at the secondary endpoints, they appear to be selected to help inform labeling discussions with the FDA, so I don't necessarily think they need to be statistically significant to get FDA approval, although sometimes the FDA may want to see a durable effect, although we do have a retreatment study ongoing. As long as we tick all of the other boxes, such as safety etc, we should be OK.

My views, dyor