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Message: Statistically proven...

"What if we get a statistical value of .06 for primary endpoint,... does that mean we didn't make the endpoint,...? Is there no wiggle room,...?"

Correct. Although somewhat arbitrary, the statistical significance threshold is 0.05. As far as I know there is no wiggle room: p<0.05 good, p>0.05 not good. So if the primary endpoint for the combined statin group ends up being p>0.05, the trial failed to meet the endpoint with statistical significant. Here's a good reference on the topic.

When the Alpha is the Omega: P-values, "Substantial Evidence," and the 0.05 Standard at FDA

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6169785/

What is unclear to me is how the pre-specified subgroup comparisons for the primary endpoint are interpreted if the primary endpoint for the total combined statin group is not met. I've read some sources that suggest that subgroup analyses of the primary endpoint and secondary endpoint analyses are not valid if the primary endpoint for the total population fails. But if the primary endpoint is statistically significant for one of the subgroups (rosuvastatin, for example) but not for the combined statin total population, then it may be up to the FDA/EMA as Tada suggested.

Let's hope for well below 0.05!

BearDownAZ

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