Mads Krogsgaard Thomsen
Management
Thank you, Kåre. Please turn to Slide 11. I’ll start with an update on DEVOTE. Recruitment is progressing ahead of plans and the majority of the 7,500 participants have now been recruited. We now expect data to support a pre-specified interim analysis of MACE to be available early 2015. Completion of the trial is still expected to be within three to four years from trial initiation in October 2013. As you know, there has been much debate on the topic of how to best use interim analysis as the basis for potential FDA action while preserving the integrity of the ongoing cardiovascular trial. Reflecting this, we previously indicated that one approach to postpone the risk of introducing bias in the DEVOTE trial for as long as possible would be to submit the interim analysis to the FDA regardless of the hazard ratio observed at the point of the interim. On August 11th, FDA hosted an advisory committee hearing on interim analysis of cardiovascular outcome trials and we subsequently also received specific guidance from the agency on the best path forward for DEVOTE. On this basis, we now expect to decide during the first half of 2015 whether to submit based on interim data or to await the completion of the DEVOTE trial. The decision will take into consideration both specific FDA guidance to the company and the general FDA guidance from the CV guideline published in 2008. I’d like to stress that our confidence in both the cardiovascular safety of Tresiba and the ability of DEVOTE to document this remains unchanged. The challenge is simply that interim analysis inherently carry a higher level of uncertainty because we have faced on a much lower number of observations than the final results. This means that there is a risk that the interim…