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
Trial controls.My take is we should do the trial this way Three...
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