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Re: end2war post# 391067

Friday, 12/09/2022 11:38:15 AM

Friday, December 09, 2022 11:38:15 AM

Post# of 463468
Anavex had to collect the raw data for an odds ratio analysis. The problem is that Anavex may not be able to prove statistical significance using a traditional analysis. There is an argument by the company that titration complicated the analysis, but that is because of the trial criteria only. An analysis could be performed on the end dosage, however that would not align with the trial design for inclusion in each group. It is a paper vs reality thing. There is no way to separate the groups into maximum tolerated dosage with a placebo arm. Undoubtedly, a negative spic could be used on any further analysis, but it is all BS.

Since the trial was blinded a post-hoc analysis should be able to be performed with maximum tolerated dosage, pooled, to show benefit. The problem will be, if the 30mg group does not show statistical significance and the 50mg group does. Again, it would be BS, but you could not pre-specify who could tolerate the drug prior to dosing unless additional biomarkers are identified. This is BS, because the drug has shown to be safe and tolerable, regardless of the dosage. Take your chances and find out... the 'take at bedtime' caveat will probably also have naysayers because there is no evidence to support this case.

A real doctor would be able to understand a post-hoc analysis and not throw thier arms up on semantics.

If the trash was taken out at 6:05, and they said they would do it at 6:00, and the trash truck runs at 7:00, the result will be the same if you're only worried about getting rid of the trash.
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