I was hoping someone else would respond as I am a layman. Let’s pretend blarcamesine is approved in some capacity and I am going to find out if I can have it. Who am I and who is my prospective doctor ? Will he need a genetic profile and am I part of another study? How will I know my optimum dose? How much will it cost? When will I or my doctor notice benefit? Anyway.thats a start
Likely, if a stumbling block, the Use and Interpretation of RAW data to achieve stated results/conclusions will dominate any questions of concern by the EMA. Many of the methodology metrics are easily agreed to or otherwise easily answered.
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