The 96-week OLE (which started in 2022) should be ending in the next few months. See below.
Soumit Roy
These are truly encouraging data. You have quite a few catalysts coming up in the next probably three months. I’m trying to understand what would be the strategy when you go to FDA, would you wait for the open-label extension on trial data to come out along with the publication and completion of the European filing and then approach to FDA with the totality of data with biomarker and the long-term, or would you do before that, meet with FDA before the long-term extension on trial data?
Dr. Christopher Missling
Yeah. So we really want to have the best impact, I would say. And you don’t have a second chance [to make a good] first impression, as they say. And certainly having data of the open-label study, which is 96 weeks, probably, would be favorable. However, we have not decided how to proceed on the timing exactly, but definitely this year. But also we can do, since it’s an open-label, interim cuts. So there’s a way to expedite the analysis of the open label study.
Soumit Roy
That is truly helpful. The last question on if you can provide any guidance on the timeline around completion of the European filing?
Dr. Christopher Missling
Yeah. So we definitely want to expedite this and the teams are working really over time to put together the modules, which are many pages, a significant package, we talk about a lot of documents and they all have to be completely ready. Usually this takes time and other companies are going through the same process need the same time. So we’re not in a different situation like that. But we said we want to submit this year and we are well on track to do that. So we will provide updated timing when we get closer to the filing time. But we have very good on time with that. So stay tuned.
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