Anavex Life Sciences Corp (AVXL)

[12x]

It’s great that you’ll be able to ask some of the questions retail shareholders actually care about.

The areas that matter most now, in my view, are the ones that clarify what CHMP actually saw and what the company can realistically bring into re-exam:

1. What exactly was presented in the first review cycle?
Were the full OLE datasets (144/192 weeks) and the ABCLEAR3 analyses included in the materials CHMP evaluated during the clock-stops and the oral explanation? Or were these only partially ready and therefore not fully assessed?
And related to this, did CHMP not recognize the company’s 48-week RCT multiplicity/gatekeeper plan (or hierarchy), and if so, what feedback did they give on that point?

2. What does “providing relevant biomarker data” truly mean for re-exam?
Which biomarker sets does the company intend to rely on — Aß42/40, tau, NfL, MRI/atrophy tied to ABCLEAR2/3, ADNI comparisons, prodromal/MCI analyses, etc.?
Given that the ABCLEAR3 reprint only showed statistically significant atrophy findings, it would help to understand whether any additional biomarker evidence exists in a form CHMP can legally consider.

3. Financing & execution risk:
Given the capital structure and the likelihood of additional trials, what is the current status of the $150M ATM (usage and remaining capacity)? And what is the realistic, funded plan for AD, PD, schizophrenia, and Rett going forward — timelines included? Retail needs concrete operational guidance, not aspirational indications.