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## Let’s get down to the nitty gritty of Due Diligence

The fact that Phase2b/3 included 30mg cohort makes it just greater n Phase2a? If this question can be aswered in affirmitive than one would expect the 30mg follow placebo, or at least expect most of the responders to reside in the 50mg cohort. Notwithstanding the fact that Dr Missling has presented the data from Phase2a on basis of concentration in blood which somehow was suppose to follow the dose. **In this iteration of my musings on Phase2b/3 results I assume the 95% membership of performers in 50mg cohort. **

**The number of responders (cognition) in both cohorts was set at 1.84 of responders in Placebo Arm**.**The averege change of scores between baseline and 48 weeks for all the responders (-0.5 or less) (both cohorts) was ADAS-Cog = -4.03****The average change of scores between baseline and 48 weeks for all patient (both cohorts) was 2.26**

The first question which comes to mind is what was the number of responders in the Placebo Arm. That was not given. What we are left with is searching for some surrogate numbers in the literature. [1] Link to resourse https://pubmed.ncbi.nlm.nih.gov/10404988/

The paper states that after one year it was observed that 23% of initial number of patients retained their score or even had better scores. For our purposed we set this number to be 170*.23=39. If one of these is a dropout then is (39/161)=24% . Therefore the least number of responders in both chorts is 24%*1.84 = 44.2% which is 139 responders. If 95% of them are in 50mg cohort that makes to be 131. There is 169 people in the 50mg cohort so 38 are nonresponders. We assume these unresponders decline with average rate. **How to obtain the average rate? ** solve equation ((-4.03)*131+207*x)/2=2.26 therefor x=2.57. **Now we can compute the average change of scores in 50mg cohort. It is -2.54. **

That computation is not the only possible since we have the data on placebo arm in Donezepil as it is presented in the fig. 2 of the Donezepil label.

This is altered plot of donezepil placebo. Original plot was for 24 weeks duration of Donezepil trial. I moved the plot additional 2 points to the right to simulate additional 24 weeks. I think that additional move to the right is warranted by 1 point. If we so alter the plot we can read that 30% of patinets still are socring better than at baseline. 30%81.84=55%. 55% of 170 is 94. So in 50mg cohort there is going to be 95% of (2*94) = 178. The number is larger than the cohort so we assume 90% are reponders 10% are average patients. **How to obtain the average rate? ** ((-4.03)*188+150*x)/2=2.26 therefor x=5.08. This rate of decline for patients is commesurate with the average annual decline for ADAS-Cog in normal disease. This makes the calculation more probable than those given above. Calculating averge for 50mg cohort. ((152*(-4.03))+(17*5.08))/169=-3.11. **50mg cohort should have averge rate of change in scores -3.11**.

## Coclusions

**It is rational to expect the 50mg cohort to have average improvement of -3.11 ADAS-Cog****In the rivalry betweeen $SAVA Simufilam and Blarcamesine there seems to be a tie for right now.**

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