Friday, July 25, 2014 7:50:34 PM
I'll just address the Reduce it part of your vent/ rant ..." Naive to think Amarn has a clear path ...no one can block it etc "
Reduce It is being run independently by a company called Pharma Net . Amarin finances it but has limited control . It's monitored by Dr Bhatt ..A highly respected Cardiologist / Scientist from Brigham Young I believe , and complies with all the FDA guidelines for a double blinded clinical trial
So it's not going to be blocked ....if it is stopped early for efficacy as we all hope ..then it may be criticized for being underpowered ( not enough patients for long enough ) or it may be criticized because of the placebo used ( JL , STS and others have explained how this criticism can be dealt with ) but as long as the results show a P value of less then .05 and there's a narrow confidence interval , results a considered stat sig etc etc ....the results will be accepted and respected .
( am not a scientist but that's my understanding of the bio stats involved )
As HDGator ...mentioned ..this is an " event " driven trial ...how many heart attacks etc .... That's what matters .."hard events " . V either lowers them when added to Statin therapy or it doesn't .
We just need to find out before they run out of cash :)
Kiwi
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