I just read the PR a minute ago. I still think the likelihood that AVXL files this year based on the single 2b/3 with either or both FDA and MAA is still 1-2 %.
From today's PR
For the primary endpoint ADAS-Cog13, blarcamesine is significantly better than placebo for both 50 mg (-2.149; P = 0.021) at 48 weeks and for 30 mg blarcamesine dosage groups (-1.934; P = 0.026) at 48 weeks. The key secondary endpoint CDR-SB was significantly improved vs. placebo in both 50 mg (-0.465; P = 0.045) and 30 mg (-0.502; P = 0.020) assigned dose groups.
From September 14, 2023
The trial was successful, since the differences in the least-squares mean (LSM) change from baseline to 48 weeks between the blarcamesine and placebo groups were -1.783 [95% CI, -3.314 to -0.251]; (P = 0.0226) for ADAS-Cog13, and -0.456 [95% CI, -0.831 to -0.080]; (P = 0.0175) for CDR-SB in patients with early Alzheimer’s disease
Note the very strange result saying 50 mg progressed 2.1 points less on ADAS-Cog than placebo AND 30 mg progressed 1.9 points less with p values around 0.021-0.26. Yet in September 2023, for 30 mg plus 50 mg using more accepted MMRM/LSM, combined dose was 1.78 fewer points progression compared to placebo and p=0.026.
There is no positive value solution for (n1+n2)*1.78 = (n1)*2.1 + (n2)*1.9 So only answer is that different cohorts were used. My guess is the new data is only using completers.(PP cohort) which is not an acceptable method for regulatory agencies. That also explains the high dropout rates (for the MMRM/LSM the mITT cohort was probably the standard of all patients who received at least one dose and had at least one post baseline visit (i.e. 12-13 weeks).
Another clue that there were different cohorts is that the p values for 1/2 sized 30 vs 50 mg groups are the same as for the larger combined cohort, compared to placebo.
The PR was written for investors not scientists or clinicians
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