QuickView: FDA outlines regulatory approval pathway
The FDA has outlined a regulatory path, based on existing clinical data, for drisapersen in Duchenne muscular dystrophy (DMD). US filing is expected later this year and will be conditional on the commitment to perform two confirmatory studies post-approval. Prosensa already has 450 patient years of data on more than 300 individuals, which suggest that drisapersen has most effect when treatment is initiated earlier in the disease or continued for longer periods. Prosensa has €77m cash (March 2014) and burns c €20-25m pa.
Edison is an investment research and advisory company, with offices in North America, Europe, the Middle East and AsiaPac. The heart of Edison is our world renowned equity research platform and deep multi-sector expertise. At Edison Investment Research, our research is widely read by international investors, advisors and stakeholders. Edison Advisors leverages our core research platform to provide differentiated services including investor relations and strategic consulting.
.
Unfortunately, this report is not available for the investor type or country you selected.
Browse all ResearchPool reportsReport is subscription only.
Thank you, your report is ready.
Thank you, your report is ready.