There is no doubt at all that MSB will need another P3 trial before approval will be granted by the FDA.
Mesoblast has mentioned in the past that their partner, Grunenthal, will run another P3 in Europe, conditional on a positive result of our current trial.
The results of that trial are years away, but if positive, would likely see approval in both Europe and the US.
Back pain read out - what are your thoughts?, page-10
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