Mesoblast CC Transcript 31/8, page-9

Trial controls.



My take is we should do the trial this way

Three groups of salvage therapy SR aGvHD patients

Group 1 - gets product manufactured for the 001 trial
Group 2 - gets product from a new manufacturing run, possibly the cells the FDA just observed during the Lonza inspection
Group 3- Ruxolitinib/Best standard of care only

1- verifies potency assay effectiveness in the trial lot
2- verifies potency assay effectiveness in future lots
3 - Demonstrates superior efficacy to Rux

100 day survival outcomes , recruit 20 a month for three months


That's my take on the CC comments , please correct me if I am on the wrong path


Reg