Daniel Vitt: Yes, I think you’re absolutely right so these are the 2 major markets we’re looking at. NFL, you may remember that from the Phase II, we had very promising activity there. And also some newer biomarkers have been added to the package, for example GFAP and others. And of course I think in this trial we may look on some functional readouts that will not be an advanced set of data at that timepoint. I think the interim is done — will be done when 50% of the patients have reached 24-week treatment. So this is early in the treatment and therefore, we think that biomarkers are the best suitable readout for such an interim analysis. And it’s really just to check do we see a difference here between the active and the placebo patients.
And just to remind you, we have the 2 different kinds of placebos, we have primary and secondary progressive patients in this trial. And that’s of course also an information we want to extract from the trial, whether for example is 1 subgroup benefiting substantially better than the other, which may give us the opportunity at the completion of the trial to consider and to maybe enrich more patients from the 1 or the other kind.
William Wood: And then will we actually get the same datas, the same biomarkers, et cetera, at the end of the trial also?
Daniel Vitt: Yes, sure. I forgot to mention it. Yes, of course this is an important part of the story to also look on the evolving biomarkers over time and changes there and that may be a very interesting readout on all of the different parameters over time, right?
William Wood: Excellent. And then just sort of taking that a step further following this, you had just mentioned that there might be some wiggle room for some adjustments based on BMS, SBMS. Do you have any plans to meet with the FDA on how they may receive the biomarkers and then to potentially adjust for both ENSURE or CALLIPER if needed? I’m just trying to understand the path forward following this interim readout.
Daniel Vitt: No, this is more for internal decision I think. There is no plan right now to talk with the FDA on the interim analysis, but of course it will influence our strategy going forward and the discussions we will then have with the complete data set later. So that’s more than the formal way of looking on this. For us it’s really important to understand the science and that’s why we’re doing these things as interim readouts. And I think we are all excited to see what’s coming out there because it’s a totally underserved area and not so many things worked so far so it’s not a low hanging fruit here.
William Wood: Makes sense. And then 1 last one, if I may. You’ve mentioned that the interim readout is currently a little to be determined, it’s going to be based on our event driven, primary area is the enrollment. Could you just give us any details on how enrollment is proceeding for ENSURE, but also for CALLIPER? Maybe commenting on if anything has been slowing it down or even speeding it up?
Daniel Vitt: Yes. I think as you know, in the past we really never gave guidance on enrollment status because if you start that race, then it’s something we have every week other questions on that. So we stick to our current guidance on the readouts. So that means we are somehow satisfied with what we see on recruitment in both trials and as soon as we figure out that expectations are changing, we need to give an update on that of course and we will do that. Excellent. Thank you so much. That it. Congratulations again.
Jessica Breu: This concludes our question-and-answer session. I would like to turn the conference back over to Daniel for any closing remarks.
