Phase 3 DREAM HF-1 read-out, page-290

I was always of the mindset that the CLBP was the more likely phase 3 trial to succeed... I could pick holes in the CHF phase 3 trial, as that's probably why there has been so much discussion on it... there is scope for debate.

But for CLBP, in my view anyway... all signs are pointing to a positive read-out. Animal studies were exactly what you wanted to see (the treated sheep ended up with almost fully healed discs), phase 2 trial results were outstanding (3x treated patients vs placebo recorded >50% pain reduction & 15 point functional improvement) and the phase 3 trial had a 1 year-blinded summary endpoint review by MSB in Mar19 which was then followed by a Europe & Latin America partnership with Gruenthal.

@dplane brought up a valid point in that the endpoints are dependent on patients providing their feedback, which is always going to be subjective and imperfect... but outside of that, I haven't come across anything that would have me concerned.

But I will caveat that with the fact that nothing is ever 100%, and large scale phase 3 double-blinded randomised placebo controlled trials are designed to rigorously evaluate the efficacy of the treatment and it'll give us a clear answer one way or the other. But in this case, I feel even if the trial fails to meet the primary endpoints in our phase 3 trial, so long as the results are higher than what the FDA has guided as approvable composite primary endpoints - then MSB could still file for FDA approval.