Ann: FDAs OTAT Agrees to Primary Endpoint for Back Pain, page-82

One thing that is easily measurable is opioid use, and for 40% of patients to voluntarily (against the advice of those running the trial) stop the use of opioids mid trial, taking into account the addictiveness of the substance... is in my mind quite telling.

the pain reduction seen in MSB's phase 3 trial was substantial, so we are not talking minor improvements in pain score here.

I'm glad to see the single primary endpoint.. I was almost certain the FDA would make it a composite with pain and opioid sparring.. which would be complimentary anyway, but this is an even better outcome.

It's also interesting to see the evolution of what would have been several rounds of guidance from the FDA to ultimately arrive at this final guidance.

If we translate that the CHF program, what guidance has the FDA given Mesoblast to alter their target population for an accelerated approval pathway? If the CLBP discussions are anything to go by... has the FDA steered Mesoblast to push for accelerated approval? It's a pretty bold move by Mesoblast, backed by strong data.. but bold nonetheless... and IMO most likely guided by the FDA.