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HDGabor

10/05/17 10:22 AM

#115570 RE: staccani #115566

s-

If you are done with Miss January, February, ... June, but you are still active and Miss July, ... December are fine with it, will you end the night or will continue?

JT, Q4 2015 CC

we don’t want to achieve the primary endpoint, stop the study early and later learn that some key secondary endpoint was trending positively, but didn’t reach the high statistical standard for success that is associated within interim look, but that might have proven success or have the trial continue to the next year or so to completion.

Best,
G

jessellivermore

10/05/17 10:25 AM

#115573 RE: staccani #115566

stacs,,,,

Quote: "How worse than 0.6% can it be? 2%? 3%? T would still be a RRR well above 50%...
Quite onesttly I am scratching my head as to why this trial has not been stopped yet."

That's very easy to answer... The RRR is going to be very high and is not the issue...The issue is the number of events needed to show strong statistical benefit in the thirty plus data points the trial is looking at...

Even though high RRRs lower the number of events needed for statistical significance; all these additional data points are fractions of the total number of Primary and non primary events and some of the data categories are "small fractions"..Since most of these data points reflect clinical outcomes if they show strong statistical significance this could be used to justify new indications for Vascepa...So it is important to collect as many events as possible and that means running the trial as long as the trial design allows..

":>) JL