I have been trying to think of a way to express this thought....and I think I finally found a way maybe.  

What I'm wondering is if its possible that BETonMACE actually could be said to have passed the Primary Endpoint?  Here is the quote from what Don said on the Conference Call:

"...the initial top line results for BETonMACE did not meet the rigorous academic requirements in confirming the primary endpoint..."

I've highlighted the words initial and rigrorous academic requirements because I think they could be important. 

When I listened to the CC I quickly formed the impression that Don sounded as though he was reading from a prepared text, I do not believe he was speaking off the cuff.  If my assumption is corect I would further assume that those words were poured over and carefully considered....probably even vetted by legal in my opinion.  

Here's what I'm thinking. 

Everyone probably knows the technical definition for a recesssion.  A recession is defined as two consecutive quarters of negative growth.  However I would submit that  most economists would recognize that a quarter of zero or just .1% growth followed by a quarter with economy shrinking by say .5%....while this doesn't meet the technical definition of a recession, I believe most economists would still consider the economy to in fact be "in recession" regardless.  

I am not a statistician, not even close.  When I saw all the posts about P value and the number of patient years and such...my eyes mostly glazed over.  But I think if I understand the thrust of the discussios that were taking place...a lot of it was centred around determining whether or not the BETonMACE trial was sufficiently powered to meet the requirement for statistical significance.  

So ultimately here's what's rattling around in my addled little brain.  

Just spitballing....What if BETonMACE achieved 40% RRR in the time to first occuance of narrowly defined 3 point MACE.  However...what if the result was not considered statisically signifcant due to a high drop out rate or some other factor(s)?

Like the recession example....where everyone knows that a recession is on, its just not confirmed by the textbook definition "yet".  Could the results for the Primary Endpoint likewise be proven, except by a textbook and/or academic definition?

Thoughts?  Am I barking up the wrong tree?  Its happened before.  TIA