Why the regal study with HR = 0.636 can still achieve a power of 90%.

Since I'm not an expert, please don't consider my post as financial advice. Everyone should verify the accuracy of this information for themselves and do their own due diligence.

BMF Reports (claiming that 80 deaths yield only 51% power at an HR of 0.636) relies on a crude, simplified, and unstratified log-rank test (Schoenfeld's formula). In contrast, the REGAL trial protocol officially utilizes the Stratified Cox Proportional Hazards Model. Stratification in REGAL divides patients into subgroups based on key prognostic variables: MRD (minimal residual disease) status, cytogenetic risk (favorable vs. unfavorable), and the duration of first remission (CR1).

When biostatisticians feed data into a stratified model, they remove confounding variables from the equation. Mathematically, this reduces variance (standard error), which automatically and drastically drives up the Z-score to a level equal to or higher than 3.0. As a result, a higher Z-score with the same number of 80 deaths shifts the statistical significance threshold and guarantees achieving the targeted power of \(\ge \)90%. BMF deliberately omitted stratification in its calculations to artificially suppress the study's power to 51% and spook the market.

The architect of the study is Dr. Fleming, who is no ordinary statistician. He personally authored the textbooks that scientists worldwide use to learn how to design clinical trials. Frankie Gerola’s (from BMF) claim that Dr. Fleming and his committee "overlooked" a primary school-level statistical power error is a highly serious accusation.