Not sure but somthing for disscustion.
The current agreed end point, 12 month reduction in pain, is to give full approval so given we now have RMAT do we need that end point for accelerated approval?
To gain accelerated approval we must have a trial at the very least ready to enroll at time of approval so we may be able to fast track the process. The BLA is also much faster for this form of approval as much of the review is left for full approval.
So the trial design may have several cohorts with a much shorter end point , perhaps 3 months, data could be obtained from the first cohort and a BLA be apapprovable in as SI would say "short order"
RMAT is a big deal.
MESO watch and banter, page-44
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