Question-and-Answer Session
Operator
Thank you. (Operator instructions) We’ll go to Edmund Kim with JP Morgan.
Edmund Kim – JP Morgan
Hi, thanks for the additional commentary regarding the Dyloject launch in the UK. I have a few questions. One, the – NDA filing for Dyloject now appears to have been kind of pushed back by six months or so. What’s the gating agent for this deferral? Is it waiting for the safety study? Could you complete [inaudible] which would be a win? And then secondly, regarding the launch in the UK, how much of your ordering are you seeing with the institutions now? And then how long after you will reach the 50% target to the 95 accounts? Do you expect to see a dramatic increase in Dyloject sales?
Marty Driscoll
Let me – to your first question, I believe it was related to Dyloject and the filing in the US and the safety study. There has been no delay. I’ve been very consistent in stating that our goal is to file the Dyloject NDA in the US in the second half of next year. And we are on pace to do that. And as we indicated in our prior conference calls, the safety study was planned to be started later this year. We actually dosed the first patients early in the month of September. So we’re on track with the timeline we have laid out on Dyloject in the US. In terms of the UK performance, the formulary acceptances have been very positive thus far, as I pointed out. We are beginning to see the ramp in the pull-through. In fact, here in the early part of fourth quarter, we’re very impressed as institutions move out their previous inventory of other products that had been on the formulary and they move to Dyloject. If we achieve our goal of 95 institutions or 50% by the latter part – or by the end of this year, end of this quarter, we anticipate the pull-through or ramp even stronger in the first quarter of next year and beyond.
Operator
We’ll go next to Adam Greene, Stanford Group.
Adam Greene – Stanford Group
Thanks. Good morning, everyone.
Marty Driscoll
Good morning, Adam.
Adam Greene – Stanford Group
Good morning. What is your run rate now in Europe, specifically to Europe and what happens to that after potential partner? And second, on the Baxter manufacturing filing, can you just explain in fact how long you think that will take with the processes rolled out, how important that is, your partnership, et cetera?
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