Mesoblast dives on FDA reports
Mesoblast shares fell 28 per cent after the US healthcare regulator released two advisory reports on Mesoblast's application to market a stem cell treatment for children with a specific inflammatory condition.
The FDA's oncologic drugs advisory committee (ODAC) briefings (serving as guidelines for an August 13 meeting) conclude it is unclear whether clinical trial results submitted provide evidence of sufficient benefit in the treatment of SR-aGVHD, or steroid-refractory acute Graft Versus Host Disease, in pediatric patients.
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