Ann: Mesoblast Phase 3 Chronic Low Back Pain Results, page-157

That is one way of looking at it. But unfortunately it wasn’t the way that MSB had designed the trial. According to MSB (as reported in the P2 study results paper):

“Responder analyses were conducted post hoc to provide additional evaluation of changes in LBP and function to be consistent with more recent guidance on reporting pain and function results in LBP clinical trials and to ensure that improvements in pain and function represent a clinically significant mprovement at the subject level.”

And so it was a responder approach they went with in the P3 trial.

In terms of the implications for missing a P3 primary endpoint?

I think if you did a survey a FDA staff and asked them which one they didn’t like the most (a) a single arm trial using a historical group comparator not derived from historical group modelling or (b) a P3 trial that misses its primary endpoint …. I think (b) would win.

But … others are right .to point out … why hasn’t the sp dropped if the results were bad. I suppose one answer might be while HC expectations were high … market expectations were low.