Shots:

• The US FDA has extended the PDUFA date for its review of risdiplam's NDA with the expected decision by Aug 24- 2020. The extension is based on the submission of additional data- including SUNFISH Part 2 study
• The company has submitted filing applications for in seven countries with submission in China imminent and currently on track submit an MAA to the EMA in mid-2020 and other international markets               
• In Nov’2019- the FDA granted PR for with a decision for approval expected by May 24- 2020. In Feb’2020- Roche has submitted some additional data which ensure access to the therapy for a broad range of people living with the condition- if approved

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