Question-and-Answer Session
Operator
(Operator instructions)
We'll go first to Katherine Xu of Credit Suisse.
Katherine Xu - Credit Suisse
Hi, good afternoon.
Jerry McMahon
Good afternoon.
Katherine Xu - Credit Suisse
Jerry, I'm just curious, during around JPMorgan in January you said, from what your estimates, you could have the topline data from the SPEAR trial by the end of this year and then now is going to be mid '09. So what happen between then and now that made you change the estimate on the timeline?
Jerry McMahon
Well, obviously we have more data so we closely analyzed our trial with respect to the data that we have since then and look at the timing of completion of the study and more importantly we really focused our analysis on the enrollment and its impact on event rates.
And when we looked at the event rates based on the data that we now have, we would expect our topline data emerging from the trial in the middle of 2009, which still allows us to file our NDA as quickly as possible. We obviously have a longer lead time on our NDA filing process and we feel very confidently that we'd be able to file the NDA in 2009.
Katherine Xu - Credit Suisse
Is the recruitment on target? I mean, basically, there are potentially two components to this one is that you are not recruiting as quickly as you anticipated. The other one is that you are prolonging safe survival and then you have less event rates kicking in right now. So I mean, to the extent that you can comment, what is--
Jerry McMahon
Yeah. I mean obviously, with our focus on event race, which is the appropriate focus? There are factors that go into that analysis and one of the factors, of course, is enrollment. We previously stated that some of the sides were slower to come up and come online than we had hoped, but now nearly all of the plan sites are up and running.
So with respect to the initial planned sites, and if we now feel that they are all online, but the impact of the lower number of sites that were up, did have an effect on enrollment and, of course, that influences our event rate even tough we now know that the vast majority of those sites are up and active. There was an impact of the slower number of event upsides that were up in running and so we did have an effect of that.
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