Great outcome for Mesoblast!
With only pain reduction at 12 months as the primary endpoint, this is much easier to achieve than pain and function as a composite primary endpoint, which was what let them down in the last trial.
If the primary endpoint is achieved (which is likely) then this will bring all of the secondary endpoints into play, with at least two shots on goal: opioid reduction and functional improvement. It would be interesting to see how MSB go about modifying the trial to achieve improved functional improvement. Will they also be looking at DMOAD (disease modifying) action? Will they also look to include an unblinded follow-up study to assess durability or will they rely on the durability findings from the previous study?
Now everyone knows why MSB have remained quiet about CLBP over the last few months.
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