"If it [SSRA] comes great, but I think its a dead issue.  The FDA news says that  we have a filing pathway right now....and right now the trial is 2,400 patients and 250 MAC events."

Far from a dead issue. The latest MD&A still references the SSRA at 75% of events (188 events). We are in limbo right now wondering if they've decided to skip the SSRA or if it is still coming. If the former, there could already be well past 188 adjudicated MACE events and they are going to likely proceed as planned with no changes to # of patients, target MACE events, or timeline. 250 events could be achieved earlier rather than later. If the latter, then there have not yet been 188 MACE events. SSRA could give a proceed as planned, or could result in recommended increases to # patients, # target events and extend the timeline. With available info and estimates, we should have hit 188 by now or VERY close. Dr. Snarkypants might have to make a re-appearance is we don't get some clarity on this on or before the AGM.

The FDA guidance means nothing in the context of the SSRA. The FDA guidance simply means that given a completed, successful BETonMACE trial that meets its endpoint(s), regardless of how long it takes, then the FDA is on board. The SSRA is an interim analysis of BETonMACE that will analyze interim data to determine if initial assumptions in trial design were correct or if changes to the trial (#patients, #target events, etc) are necessary improve its ability to make the correct success or failure call.

Far from a dead issue, IMO.

BearDownAZ