Chairman in todays annual letter:
Mesoblast plans to seek potential approval of this therapy in the highest risk
patients. In parallel, we will continue to pursue an accelerated
approval pathway for remestemcel-L in the treatment of
children with SR-aGVHD, a life-threatening condition with
no approved therapies for those under 12 years of age.
http://www.mesoblast.com/images/MSB_2020_Annual_Report_FINAL.pdf
I see treed has posted similar in another thread. Thought i would cross-post it here as well.
MSB to dispute FDA finding in Type A meeting, page-726
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