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nidan7500

06/27/20 10:25 AM

#256514 RE: georgejjl #256509

Please, confirm the following statement of mine.



Top-line results from the Anavex PDD trial should be very easy and quick to analyze using computerized statistical analysis programs that are commercially available.



This stands out to me as an opportunity for complete evaluation and system validation according to a plan and protocol acceptable to an informed body/regulatory body. So, get this validated for the intended purpose first.

I have confidence in results which can be directly measured and which are reproducible.

I would have confidence is our ability to do this motion testing/motor scores.

MDS-UPDRS Part III Total Score (Motor Scores) [ Time Frame: 14 weeks ]
Change from baseline to End of Treatment as measured by MDS-UPDRS Part III Total Score (Motor Scores)

https://clinicaltrials.gov/ct2/show/NCT03774459

BTW, if Dr.M. has established this criteria and AVXL capability to do proper V&V, then I have confidence also.

WE are not BIIB, it is what it is. The results must be consistent and reproducible.