Replies to post #508123 on Anavex Life Sciences Corp (AVXL)

[boi568]

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.

[Steady_T]

As I parse the regs and the statement by the company, I get two things. First, the company can address the concerns raised by the OE and provide data to the CHMP to address those concerns. Second, the reexamination can not include information that was not presented during the first examination. That means information provided prior to the final vote is eligible for consideration and reexamination.

To me that means that Anavex has a window of opportunity between now and the December meeting to provide additional information that has not been included in the original MAA. Once that window closes in December the record is closed and the reexamination will not get any new information for it to consider.