I think what you are referring to is this statement by the EMA
In addition, the analysis had methodological issues which raised concerns about the validity of the results
I believe they are referring to using extremely optimistic numbers to calculate power from the JPAD article
Sample size and power calculations were based on a simulation approach with several planned scenarios and assuming co-primary endpoints (ADAS-Cog13 and ADCS-ADL). The sample size calculation assumes the mean difference between either blarcamesine arm and placebo of 1.5 points (SD=4.5) in the ADAS-Cog and ADCS-ADL with at least 90% power using a two-sample t-test with alpha = 0.05 (2-sided). For the calculation of power concerning co-primary endpoints, conservatively assuming that power can be independently calculated [33], this will achieve at least 80% power for two endpoints. A 33% dropout rate was considered in estimating the sample size based on earlier studies. Therefore, 509 participants would need to be enrolled to allow for an anticipated 342 completers, i.e., 228 patients per combined treatment and 114 per placebo arm, respectively.
On the surface this sounds ok ---- but where in the world did they get std dev 4.5. Every trial using ADAS-Cog gets std dev about 7-9 (including the actual blarcamesine trial.
By my calculations using their '1.5 points (SD=4.5)' and using power of 90% for each endpoint requires 426 patients or (635 patients before expected 33% dropout That's close to the 509. Now use realistic stddev of 7.5 and you get 1182 patients needed (1764 patients before dropout) --- this is not a little matter. Its a methodological error raising concerns about the validity of the trial
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