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georgejjl

12/09/22 1:50 AM

#390932 RE: B60611 #390930

A p-value of say .055 (1 out of 18) is NOT a failure.

Less than or equal to 0.05 (1 out of 20) is an arbitrary number for significance.

The threshold value, P < 0.05 is arbitrary. As has been said earlier, it was the practice of R A Fisher FRS to assign P the value of 0.05 as a measure of evidence against null effect. One can make the “significant test” more stringent by moving to 0.01 (1%) or less stringent moving the borderline to 0.10 (10%).

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4111019/

Good luck and GOD bless,,

Anshu2

12/09/22 5:28 AM

#390938 RE: B60611 #390930

Thanks for your analysis.

I believe there were (or were very close to) 25 Blarcamesine and 5 Placebo to achieve +3.5 on ADCS-ADL



Isn’t this a poor result? I mean claiming just 25 patients (8%) of you 340 did great can never be a basis of approval —- without talking about how badly the remaining 92% did. What if the remaining 92% did WORSE than placebo on ADCS-ADL?

ChrisMissing

12/09/22 7:11 AM

#390954 RE: B60611 #390930

Is it possible that the FDA and Anavex have discussed the 30 mg and 50 mg separate trials and they can standalone. Yes they did pool the data to release the information they released but maybe there has been an agreement with the FDA that if either one or both trials pass they will approve. So if the 30 fails and the 50 passes we still get approval for the 50.