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Re: WilliamMunny post# 458338

Sunday, 05/05/2024 5:05:03 PM

Sunday, May 05, 2024 5:05:03 PM

Post# of 461946
According to Missling we are applying for full approval based on EMA feedback, but I think there's a chance that, since AD is such a pressing and large indication and our data is relatively limited, the CHMP recommends to the EMA that our application go AA and be changed to a CMA (the two are often granted together). In other words, faster but with commitment to a post-marketing confirmatory study. We should know later this year.

While we're discussing the EU, folks should keep in mind that the EMA gave feedback to us, not to the CHMP. The CHMP assesses submissions and makes recommendations to the EMA.
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