A confirmatory RCT trial may be required as so far Anavex haven't run any as would be the norm. The outcome of the P2b/3 ended up looking more like a P2 trial than a P3 pass to protocol on all endpoints met with flying colours.
If a P3 RCT Confirmatory trial is a condition under CMA, then there are plenty countries to run the trial in where blarcamesine is not approved or marketed.