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. 2024 Sep 4;7:232. doi: 10.1038/s41746-024-01211-8

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© The Author(s) 2024

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Fig. 2 — Overall, the advice period lasted 7 months, which was preceded by the compilation of the briefing book (5 months). Validation comments from the European Medicines Agency (EMA) were received 3 months after submission. After submitting a revised version of the briefing book, the consortium received a list of issues that were addressed in a written response as well as an online meeting. The final Qualification Advice was received 7 months after the briefing book submission. Submissions by the consortium are shown in blue, CHMP responses in brown and meetings in green.