MSB to dispute FDA finding in Type A meeting, page-221

have you looked at the two other trials?

put simply the first two RCTs can be distinguished by the fact they were for early onset aGVHD and a mix of lower and high grade SR-aGVHD.

in totality, remestemcel-l was not statistically more effective against standard of care.

This more recent trial was more weighted to severe cases and that that is where Ryoncil stands out... by a long shot.

But the FDA still can’t see past two failed RCTs, even though they were fundamentally different trials with what MSB purport to be a less potent product.

It defies logic and a pinch of leniency was expected given the high mortality rate.. so that is why so many people got caught out on this one.

In my view it was more likely to get approved than rejected, but I was clearly wrong. But it is now important to take a step back and try see where the FDA’s head is at to figure out how they are likely to act going forward.