My understanding (I could be wrong) is that the futility analysis (FA) interim analysis was delayed and will now occur at the same time as the sample size re-estimation analysis (SSRA) interim analysis. No interim analysis has been performed to date. DSMB safety reports are not the same as interim analyses as we discussed recently.

At the beginning of the trial, two interim analyses were planned. 1) Futility analysis (FA) at 50% of planned events (125 events); and 2) Sample size re-estimation analysis (SSRA) at 75% of planned events (~188 events). This was still the understanding as of the MD&A filed July 2017. Many including myself were expecting this FA around mid 2017. It never happened. See below.

In the Sept 2017 MD&A, it stated "A futility analysis is planned after 50–75% of the primary MACE events have been adjudicated." That was a change. Instead of 50% now it is a range of 50% to 75% to trigger the FA. No mention of SSRA interim analysis. This implies that the FA and SSRA may happen at the same interim analysis if FA occurs at 75%, or at separate interim analyses if the FA comes before 75% of events. Hard to know when to expect 75% of events if we don't know when 50% of events happened. 

In the Dec 2017 MD&A, it first stated "A sample size reestimation analysis is planned after 75% of the primary MACE events have been adjudicated." Poof. The mention of FA interim analysis disappears and this is the same language used in 2018. In my opinion, this implies that the FA and SSRA interim analyses will both occur at 75%. This is huge. Could happen any day now. If we get the SSRA announcement before or around the end of May 2018, and importantly if there are no changes, then I project we could hit 250 events as early as end of Sept 2018, but more likely Oct 2018.

However, it should not be ruled out that an FA component of the interim analysis may halt the trial for futility. Highly unlikely to be halted for potential amazing efficacy due to the short treatment period (up to 2 years) of the trial. I recall DM making a similar statement that most CVOT trials go longer and this 2 year treatment period is really the minimum they can get away with and still rely on this single trial for EMA/FDA applications. So no cutting corners by stopping early.

The SSRA component of the interim analysis might result in more patients/target events being added. Before you jump on this and reply with blah blah blah, DM said no changes and topline by end of 2018, blah blah blah.....remember the provisions of safe harbor and forward looking statement, etc. Resverlogix/DM is projecting based off of current info. The interim analysis hasn't happened yet. Once it does, then Resverlogix/DM can use that info to revise their estimates. Best case scenario, no changes. But changes are possible.

All in my opinion. Do you own due diligence.

BearDownAZ