FDA advisory committee thumbs up on Mesoblast's Ryoncil
Aug. 13, 2020 5:05 PM ETMesoblast Limited (MESO)By: Douglas W. House, SA News Editor1 Comment
• The FDA's Oncologic Drugs Advisory Committee voted 8-2 backing approval of Mesoblast Limited's (NASDAQ:MESO) Ryoncil (remestemcel-L) (ex-vivo culture-expanded adult human mesenchymal stromal cells suspension for intravenous infusion) for the treatment of steroid-refractory acute graft-versus-host disease in pediatric patients.
• The positive vote surprised some observers considering the issues cited in the review team's briefing document.
• Trading, suspended this morning pending the outcome of the meeting, has yet to resume.
Congrats all especially The prof and board, what a moment for stem cell as well!
Ryoncil: ODAC/FDA Meeting Discussion, page-1684
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