"The share price rebounded upon the announcement that the FDA Advisory Committee voted in favour of Ryoncil and that the available data supports the efficacy of Ryoncil in paediatric patients with steroid-refractory acute graft versus host disease. The Advisory Committee makes recommendations to the FDA regarding the safety and efficacy of drugs based on the available data. The FDA will consider the recommendation of the committee however the final decision regarding the approval of the product is made solely by the FDA. Ryoncil has been accepted for Priority Review by the FDA with an action date of 30 September 2020. If approved, MSB plans to launch Ryoncil in the US in 2020."
