Missling never said 18 months that was just the posters personal view based on Anavex slowness. Missling simply said would apply to FDA after MAA and OLE data (which seems most likely in September). Missling said six weeks ago in the Q2 call "definitely this year" so 18 months away for FDA submission seems a bit of a negative viewpoint from the poster.
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 for 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.
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