It appears that Anavex will be able to provide many of its new analyses upon a re-examination if the Leqembi precedent is followed. In that case, Biogen/Eisai were allowed to use an APOE4-based subgroup analysis to help reverse a negative opinion on re-examination. Critically, APOE4 was a pre specified variant in the clinical trial.
By this standard, Anavex would be able to update its MAA with the OLE early start/late start analysis, any ABCLEAR1 (S1R WT) performance in the OLE, apply ABCLEAR1 results to the MRI scans, as well as to individualized performance correlating brain retention data against cognitive results. All these elements were present in the trial design. I do not know if the ADNI time saved analysis would be allowed. However, because the ABCLEAR2/3 groups were not pre specified they would remain outside the scope of any new submission, no matter how impressive they are.
These conclusions are based simply on how the EMA applied its re-examination ground rules in the Leqembi case.
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