Cell Therapy News/Articles, page-8829

Can someone please provide a contrary view to mine as I'm getting way too excited as this appears to me to be close to the holy grail of MSC approval.

In his paper Dr Galipeau is referring to the discovery "of surrogate biomarkers of human subjects reflective of a biological predisposition that are predictive of MSC response prior to or following initiation of therapy"

And here's the BLA from the FDA for SR-aGVHD - surely such a discovery as Dr Galipeau's if accepted by the FDA would give MSB the ability to answer both of the questions posed thereby breaking down any roadblocks to not only SR-aGvHD but all MSC therapy? No?



Here's the ODAC discussion minutes - again Dr Galipeau's discovery surely moves these arguments along (noting that there was really only one dissenter on point 1 (I'm guessing we know who that was)