Mesoblast chief medical officer Fred Grossman said there is clearly a significant un-met need in steroid-refractory aGVHD.
"We already have a plan to move forward with our adult protocol, and that should be under way in the very near future," he told analysts.
"We're very encouraged by today’s outcome and are committed to working
closely with the FDA as they complete their review of our submission regarding approval of Ryoncil for this life-threatening complication of an allogenic bone marrow transplant,” he added.Dr Itescu said Mesoblast has built its leadership and sales team out in the US in anticipation of the FDA's decision as it gets ready to go to market. There is a team of 20 people to cover all regions, which will work with the various US payers, he said.
https://hotcopper.com.au/threads/questions-for-msb-management.5962105/page-68?post_id=51845799
I think these comments were made prior to ODAC. It reads that way.
As such, they knew prior to ODAC and had a trial design then. Apparently.
Take it up with SI and tell us what he says. Or not - doesn't suit your rhetoric?
Taken up the entitlement?, page-410
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