ggwpg: Let's agree to disagree, but bottom line
we've only enrolled about 800 patients since
October of 2013. That's 8 months, and very
modest. The event rate is based on the Power
of the trial and Hazard ratio. Being fully
enrolled is essential to hit the event number
sooner rather than later. The first 2,000 patients
were not representative of the higher risk patients
we desperately need. Ketchum,(CMO) was obsessed with
enrolling patients so that they would be "substantially
enrolled" so as to file Anchor. Most of the first 2,000
Pt's had Trigs at or slightly above 150mg/dl, and was
finally changed with FDA approval, to >200mg/dl. Most
folks on this site dispute this factoid, but one only
needs to call IR to confirm this.
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