There you go... the reason for the Ryoncil BLA Resubmission delay
They were waiting for this - I feel better now
I'll see you guys at the AGM - I'll be in a blue top, so come over and say hi if you are in the room!
Key Points:
• Long-term survival evident through 4 years in children treated with remestemcel-L in Phase 3trial MSB-GVHD001
• Overall survival at 2 years was 51% in remestemcel-L treated children and 25-38% in recentlypublished studies of children or adults with SR-aGVHD who received best available therapy(BAT) or the only approved agent in adults1-4
• These results reaffirm the potential significance of remestemcel-L as a life-saving therapy forchildren with SR-aGVHD
• These long-term survival outcomes are a key component of the Biologics License Application(BLA) resubmission to the United States Food and Drug Administration (FDA)
Ann: Long-Term Survival for Acute GvHD Treatment with Remestemcel, page-5
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