FDA ODAC Meeting Material discussion analysis, page-353

Stockrock, the issue of manufacturing and quality control is thoroughly addressed in the company's briefing information provided. It has been established that the cells potency is directly linked to increased survival rates. Primarily, TNFR1 levels influence day 100 survival rate and this can be accurately monitored.
The importance of TNFR1 levels is further highlighted with data mined from Protocols 265 and 280 results compared to GVHD001 (the fact that there is a direct correlation between TNFR1 levels and outcomes and that Remestemcel- L performed better in paediatrics and more critical cases) .
I am confident that the company has addressed all of the FDA's concerns in their briefing.
When you consider that Ruxolitinib was approved on a single arm study, it's of limited efficacy and poor OS in severe desease with significant adverse reactions and toxicities (Day 28 OR 42%) and the fact that there is no approved treatment for those younger than 12 year of age, the FDA must approve Remestemcel-L. I am very confident that we will receive approval.