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Mesoblast dives on FDA reports – The Australian Financial Review
The US regulator has more questions for Mesoblast over its application to market a stem cell treatment for an inflammatory condition in children.
The reports also suggest it is unclear if the durability of the trial patients’ responses require continued infusions of remestemcel-L, while suggesting the FDA’s advisory committee consider the relevance of two previous trials that failed to meet their primary end points.
The August 13 advisory committee is scheduled to include discussion as to whether or not an additional clinical trial in SR-aGVHD patients is required for confirmation of effectiveness of the product. The committee is also sc…
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