Re: Resverlogix Announces Filing of Quarterly Financial Statements and Management's Discussion & Analysis
posted on
Sep 13, 2017 10:25PM
Two interesting comments in the MD&A regarding the futility analysis (thanks for your post on SH General360).
"We have enrolled in excess of 75% of the approximately 2,400 patients outlined in the study’s protocol. A futility analysis is planned after 50–75% of the primary MACE events have been adjudicated."
"The DSMB will conduct additional periodic reviews and a futility analysis is planned after 50-75% of the primary MACE events have been adjudicated. We, the clinical steering committee, and all investigators remain blinded to the actual safety and efficacy results."
All previous statements have indicated that the futility analysis would occur after 125 adjudicated events (out of the 250 total). This "50-75%" is a new statement. If they just said "50%" no one would blink an eye. But "50-75%" raises some eyebrows. I recall Sweeney stating that in addition to the futility analysis at 125 events that there was a sample size estimate analysis planned at 175 events. Maybe at this 175 event point a second futility analysis is to be done? Perhaps there are two planned futility analyses: one at 50% (125 events) and one at 75% (187 events)? Though 187 does not equal 175. Perhaps I misheard Sweeney say 175 events and it was 75% of events. Or maybe the BETonMACE trial protocol has been amended due to the pending addition of US patients and part of this change was a modification of the futility analysis schedule. I dunno. Another head scratcher to add to the list.
BearDownAZ