Randy ...re interim looks ...you may want to read up on this
Adjustment may need to occur to preserve the overall Type I error rate of the study Every time the data is analysed, there’s a 5% chance of making a Type I error, if a=0.05. As the number of analyses increase, the chance of making a Type I error also increases. As a result, an alpha adjustment is often required. Approaches for alpha adjustment An alpha adjustment is needed to preserve the overall Type I error rate. Not surprisingly, researchers have established different methods to account for multiple analyses and ways to adjust the alpha. There isn’t any one consensus but there are a few that are commonly used. Pocock o Same alpha for interim and final analysis o 2 analyses, a = 0.0294 Haybittle-Peto o Very strict alpha adjustment at interim, no adjustment at final o 2 analyses, a = 0.002 at interim and a = 0.05 at final O’Brien-Fleming o Strict alpha adjustment at interim, small adjustment at final o 2 analyses, a = 0.0054 at interim and a = 0.0492 at final.
--------------------- This is a small Phase 2 trial they will use ( if stat sig ) to persuade the FDA to authorize widespread use of IV RLF-100 for hospitalized Covid patients .
They need this data to have the lowest P value possible .