Then you translate that into the statistics for the studies on where you need to rule it out on a hazard ratio basis, and I’ll go through that. But our trial essentially mirrored the diabetes guidance for absolute risk, the relative risk or the hazard ratio scores, then we need to rule out a doubling of risk for approval and a 40% increase in risk for the final analysis. An event-driven trial, so that means we need about 87 events to do that with high confidence for the interim analysis, and the trial is basically a very simple, straightforward study that’s tracking heart attack, stroke and cardiovascular death. That’s the primary and secondary endpoint, and an intent to treat basis.Read the rest of this transcript for free on seekingalpha.com
Orexigen Therapeutics' CEO Presents At Bank Of America Merrill Lynch Global Healthcare Conference - Special Call Transcript
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