Will someone going to the annual meeting ask these questions:
1. If the P2b/3 primary and secondary outcome measures were so excellent, why has Anavex decided to use the Accelerated Approval route? If the three Alzheimer's cognitive and patient functionality test results clearly met their endpoints, shouldn't AA be unnecessary even if the FDA relied on it for lecanemab? If the results were so good, isn't it a step backwards to pursue AA's conditional approval instead of the outright approval a non-AA application would provide?
2. Can you please tell us the n numbers for the Odds Ratios used in the results for ADCS-ADL and ADAS-Cog – the number of treated patients and, separately, the number of placebo patients in the Odds Ratio numerators for each of the two tests; and if you are not stating those numbers, why have you not done so already since you must have known them for many months?
3. Can you please tell us the before-and-after mean scores for the placebo and treated groups for each of the tests in the primary and secondary outcome measures; and if you are not stating those numbers, why have you not done so already since you must have known them for many months?
I don't regard "the answers are coming soon" as an adequate reply; if that's the answer, I'd like follow-up questions asking specifically why he has chosen not to reveal this information earlier.
I'm not trying to debate these questions here, as I'm sure we all agree only Anavex can provide real answers to them. What I'd like in replies is whether anybody who is going to the meeting will ask those questions, regardless of whether you already planned to ask them or if you would ask as a favor to me (and to anyone else on this board who would be interested in Missling's answers). I would greatly appreciate it if you would.
Thank you!!!
