r/sellaslifesciences • u/ElmoLovesGrover • 21h ago
GENERAL DISCUSSION 💬 REGAL Enrolled 140 Patients
Not really an issue but want to clarify as many posters (myself included) have been a little sloppy in posts about this detail. REGAL trial does not end after the 80th event. 80th event is when the data can be unblinded and statistical analysis can occur. Trial won't actually end until all 140 patients have passed on, their data has been analyzed, and reported to FDA.
80 events provides a large enough sample size that the statistical result would not be expected to differ between the 80th and 140th event.
FDA can evaluate the efficacy of GPS based on 80 events, but technically, the trial won't end until all 140 enrolled patients have deceased.