Re: Next Hurdle
posted on
Jan 05, 2018 12:12PM
Toinv and Golfyeti,
I don't recall DM ever saying in the webcast, nor do I see in anyone's notes, indicating that the futility analysis has been cancelled or that there is no need for a futility analysis. Please provide the statement that you are interpreting for this.
What we do know from a recent MD&A is that the futility analysis is no longer occurring at 50% of events and could occur between 50% and 75% of events. What we also know from the AGM Q&A is that a sample size estimate analysis will occur at around 188 events, which is about 75% of events. My interpretation is that a futility analysis and a sample size estimate analysis will both be done at 75% of events (188 events).
Positive DSMB reports are not a substitute for a futility analysis and are not indicative of a drug meeting its primary endpoint with statistical significance. Plenty of drugs pass DSMB and interim futility analyses and end up failing to meet their primary endpoint with statistical significance.
BearDownAZ