Feb 7 Missling said " Regarding the EMA submission, we said that we like to do this as soon as possible in 2024 and that’s exactly what we’re doing. So we are really very active on preparing every module and to submit it.
So even now it's likely the submission hasn't taken place just yet. If submitted in May we could be looking at 2025 summer time frame before we get an answer. We would likely get FDA accelerated approval much sooner. Also the peer review.
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