Q2 August 28, 2019
► Regulatory and ethics approvals progressing according to plan – by mid-August
approvals had been received for USA and 8 of 11 planned European countries: Norway,
Germany, France, Spain, Belgium, Poland, Sweden and Denmark
► Site initiations progressing according to plan with a total of 15 sites across 7 European
countries open for enrolment and actively screening for patients by mid-August
► Orphan designation granted in both the US and EU
► Fastest way to market determined through regulatory interactions with authorities
► The prevalence of bile duct cancer is higher in Asia than in the western world
► Feasibility study in Asia ongoing to select the most appropriate RELEASE study sites for
patient recruitment and market impact, with the aim to open sites in 2020