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.
So we went, then, and raised the capital and we’re lucky to have the institutions that put the money in to fund that large outcomes trial. That trial is about a 7,000 to 10,000 patient study, where we need about 90 events at the interim and about 370 events at the final. It’s an event-driven trial. And then we set out to rapidly enroll that trial, so that we could get the answer sooner, and pull forward the ultimate introduction of the product and the generation of the data.
We have announced two times now since we started the trial in June that it’s going faster than expected. In our last announcement, which I believe was last week, we said we’ll actually fully enroll the trial in this calendar year. So it’s an unprecedentedly fast enrolling trial. And I think one of the reasons it’s enrolling so fast, first it’s a bit of a proxy for the pent up demand in the market. Because the value proposition for the study is weight loss, value proposition.Read the rest of this transcript for free on seekingalpha.com
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