There is a great chance of receiving the approval.
Australia’s Mesoblast Limited has a target action date of September 30 for Ryoncil (remestemcel-L) for the treatment of steroid-refractory acute graft versus host disease (SR-aGVHD) in children. On August 13, the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted “overwhelmingly” in favour of the efficacy of the drug in pediatric patients. Although the FDA is not required to follow the advisory committee’s recommendation, it often does.
But lets say its not approved? Does this mean the end of world for Mesoblast? The company is not going down and they will still have option to file a review. Check out the case of Aquestive Therapeutics.
Lets not panic and avoid doing what happened with DXB.
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- FDA does not over-rule positive ODAC decisions
FDA does not over-rule positive ODAC decisions, page-58
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