Ann: FDA Advisory Committee Sets Review Date for Remestemcel-L, page-397

You are right when it comes to their attack on the phase 3 based on lack of a randomised control group, but they also attack the use of a 45% overall response rate as the historical control which they say is too low. We have no way of knowing how weighty this criticism is. I expect MSB has the internal/proprietary data needed to back up its figure. They have done much more work in children's aGvHD than anyone else and they have the data to show for it. I don't believe they would have come this far without having this squared away. But even if it is on the low side, I think rem'l will still be viewed as an effective & side effects free treatment. If we get a unanimous or majority vote from AdCom then I think an approval for Covid19/ARDS is also pretty much in the bag.