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georgejjl

04/27/23 4:01 PM

#412682 RE: bas2020 #412680

The median score is more important than the mean score because the median is NOT affected by any outliers and the shape of the distribution like the mean score. The median tells us that 50% of the sample is above the median and 50% are below the median.

Good luck and GOD bless,
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sab63090

04/27/23 5:49 PM

#412691 RE: bas2020 #412680

Thanks, I saw that...I have not as yet gained confidence until it is stated by Dr. Jin...sorry, but I find Dr. Missling's assurances not yet confirmed by Dr. Jin....or....Dr. Ma
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Joseph_K

04/27/23 7:15 PM

#412707 RE: bas2020 #412680

That mere "one endpoint" is one of only two Primary Endpoints. So it's a big deal. Here it is:

Reduction in decline of the ability to perform daily activities assessed from baseline over 48 weeks with ANAVEX2-73 compared to placebo using the Activities of Daily Living Scale (ADCS-ADL)



From the information the company has provided, it appears to me that they are not meeting the endpoint that they themselves established. Maybe the Odds Ratio for improvement is so awesome (which means not only a high ratio but also plenty of patients who crossed the threshold) that Missling believes the FDA will accept what is really a substitution for the original endpoint ("reduction in decline")*. And I immensely hope the FDA does. But Anavex really hasn't provided any analysis or data supporting the actual endpoint, the one specified in the clinicaltrials.gov entry.

If you think it has, please tell me: What was the "reduction in decline" of the drugged patients compared to those on placebo? (I believe this comparison makes sense only when applied to the entire Intent To Treat population.)

*Along with the other much-less-disputable positives of blarcamesine, such as its safety profile, biomarker results, and proven efficacy on other measures.