You want positive sounding?? From the top dogSlide 22 shows the...

You want positive sounding?? From the top dog

Slide 22 shows the long-term survival outcomes from the children in our pivotal study 001. Of these 51 children of whom almost 90% were grade C/D disease. You can see that by -- through the end of the fourth year into year five, almost 50% of children maintained survival. And really, survival through year five indicates curative outcomes. And those children arrived at year five are really living normal lives. And we have children who are now medical students, for example, thriving in the community. In contrast to this long-term outcome with remestemcel, you see the outcomes in five publications in children and adults treated with alternative therapies, including ruxolitinib.

And you see that across the board in each of these studies, day -- year one survival is in the 40% range. Year two survival is in the 20% to 30% range, and there are no reports of survival outcomes beyond year two. We think the long-term survival outcomes with remestemcel from a pivotal Phase 3 trial is unparalleled with other therapies that are available today. Slide 23. So what is the regulatory status and pathway for RYONCIL in children. As I've mentioned earlier, we have an FDA meeting scheduled and upcoming for March with the FDA where we have provided the agency with a substantial amount of new data from a second potency assay for our product RYONCIL, providing additional product categorization as requested by the FDA. The new data show that the RYONCIL product, optimized and improved RYONCIL product made with the current manufacturing process that has undergone successful inspection by the FDA demonstrates greater potency than the earlier generation products.

Reg