With the full NDA review they identified one approval deficiency, which is a large one for us, which was to rule out excess cardiovascular risk. We then took about 9 months to clearly identify with the FDA what the hurdle was, to rule out risk, and as it turns out it’s very similar to the diabetes guidance, where you can get on the market with an interim look, of a large outcomes database, and rule out a certain level of risk.For us, that risk capping is we have to rule out a doubling of risk at the interim, and then that would warrant approval, and then you move on to the final analysis, which would rule out about a 40% increase in risk. The absolute risk that we’re ruling out is identical to what’s ruled out in a diabetes patient population, in terms of number of excess cardiovascular events.
Orexigen Therapeutics' CEO Presents At Morgan Stanley Healthcare Conference (Transcript)
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