MSB Trading - Aug 2020 on, page-907

From the financial review

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's 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.
The stock fell to $3.50 on Tuesday.
However, the ODAC did acknowledge that Mesoblast's study reached its primary endpoint of a 28-day overall response rate in patients at 69.1 per cent.
The reports also suggest it's 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 endpoints.
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 scheduled to discuss what trial design would be required to provide evidence of effectiveness.