Question-and-Answer Session
Operator
(Operator Instructions). The first question comes from the line of Jack Gorman with Davy.
Jack Gorman - Davy
I just had a couple of questions on the final piece of information on the Phase 3 design that you shared with us, Lars, I suppose in the first instance my first question would be is there a plan or it's in the protocol to include interim analyses over the course of the 18 months of data? And secondly, is there any update that we can have from you on the filing and the manufacturing strategy that you have for Bapineuzumab and the other AD programs?
Lars Ekman
Okay. The first question is related to an interim look. It is premature at this point to give information of that since we have not received a specific feedback from all the regulatory agencies at this point. Once we have that information that will become available.
Jack Gorman - Davy
But when do you expect those?
Lars Ekman
I don't want to speculate in when and how that will happen, that's part of the dialogue that is ongoing.
Jack Gorman - Davy
Okay.
Lars Ekman
And the next question was related to our manufacturing capability?
Jack Gorman - Davy
Yeah, yes.
Lars Ekman
Perhaps I can turn it to you Kelly for that.
Kelly Martin
Yes. Jack the Wyeth and Elan teams have been working extremely hard on the manufacturing topic over the last six to nine months and I would characterize where we are today as I think that we collectively have an extremely good manufacturing plan. We believe that we have the manufacturing topic well in hand; Wyeth has done some extremely good work in the biological area. And we feel very good collectively between Wyeth and ourselves where we are with manufacturing plan, manufacturing preparation and overall supply capability as we look out into various scenarios.
Jack Gorman - Davy
And Kelly, I know you mentioned previously that one of your intentions was to have your own manufacturing capability at some stage, is that still a fair comment?
Kelly Martin
We are in the process of finalizing things with Wyeth. I think this capability is within both companies that we can leverage, which we will do. And given the magnitude and the importance of this product to both companies and obviously the magnitude of the market, I think its fair to say that we will both be participating in the manufacturing processes and those details will be released as we reach completion on the manufacturing plans. But we believe that it's important for us to be involved with this, given the partnership with Wyeth and given the magnitude of the opportunity and the magnitude of the business.
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