Jo Walton - Credit Suisse Securities (Europe) Ltd.
Thank you. I have two questions. Firstly, I wonder if you could confirm for us whether you think you're going to need an AdComm for lanadelumab and Resolor in the U.S. And secondly, again on the HAE scene, I wonder if you could break out for us or give us some more data behind the CINRYZE and FIRAZYR breakdown. In particular, we're obviously interested in the CINRYZE supply situation and also the impact of HAEGARDA in the U.S.
Flemming Ornskov - Shire Plc
Yeah, thanks very much, Jo. I will -- not to monopolize the conversation, but just want to give you a little bit of intro remarks. So we have not properly confirmed anything about – or I don't think that the regulatory agency, the FDA, has regarding advisory committees for either of those products. If I had to guess, I would say the likelihood is probably higher for prucalopride than it is for the other, but I do not know, just because of the filing. But we have no confirmation, yes or no, publicly about either of those.
If it should happen for either or both, I can assure you my team is totally prepared to address any questions in both cases. We see both of these products currently on track to the timing we've laid out with their PDUFA dates. But again, it's early in their filings. I note with lanadelumab, I think it's – if I have to say it on behalf my team, I think they've done an outstanding job, because not only have they accelerated reviews in the U.S., but you've seen the same for EU and Canada. So I feel very strongly about this. And I think both products will be future good growth drivers for Shire.
As pertains to CINRYZE, hereditary angioedema, and FIRAZYR, as you can imagine – and a new competitive entry with HAEGARDA, some of the same things we've said before, that the supply patterns for CINRYZE has been a bit erratic at the end of last year. It is starting to get better. We have moved U.S. production to Vienna. We still have international production coming out of Sanquin, and I think that is starting to become more normal and more normalized.
And the other thing we're seeing is that in the marketplace, having a very strong patient service organization to support the patients as they roll on to the products is very important. And I think we have a very strong leg to stand on in the U.S. with our OnePath service organization. So, I feel very good about both of those situations. Thomas, anything you want to say about FIRAZYR?
Thomas J. W. Dittrich - Shire Plc
I think we don't break it down. We feel very confident and I would not take small ups and downs in the quarters with stocking, destocking, filling the supply, given that you come out of a out of stock situation in the second half of last year. It's going to take a little bit longer before that is normalized. What we do see is that, anecdotally, that patients continue to be very pleased with their treatment of CINRYZE, and I've also anecdotally heard about patients that had switched and are coming back.