RE:RE:Q: Still dosing?Slide 17 from the
Sept 2018 AGM states "
Adaptive trial options – stop dosing at 230-235 events and wait for 250 events or stop at 250 events and probably accumulate 270+ events?"
In my opinion, that statement was referring to "230 to 235" or "250" adjudicated events as the end of dosing trigger. Perhaps those were the options at the two extremes. Today's news release indicated that
"Current adjudicated events exceed 90% of the 250........
Those sites with the most patients enrolled will commence [Last Study Visits] first, followed by the others. This will allow additional time to build the overall MACE events to about 260 or greater while not slowing down the trial’s move towards final database lock." The more I think about it, it seems that they are choosing a hybrid approach. They don't have 250 adjudicated yet, but it does not seem like they are ending dosing in all pateints yet. As I suggested in my previous post, one way to interpret the LSV statement is that they will be doing a rolling/progressive end of dosing. I now favor this interpretation. They have 250 events (with at least 90% adjudicated) but BETonMACE will continue to accrue on-treatment patient years and events until each patients respective LSV, at which time a patient will stop dosing and no longer contribute patient years or events to the on-treatment analysis. A very smart way to do it!
BearDownAZ