Uit het transcript betreffende CF.
Voor mij enige geruststelling; er is intensief overleg met AbbVie over de strategie en volgens Piet Wigerinck gaan ze echt verder met de Fase IIb in de U.S.
So first question was about timing of the triple. So we've always said it would start around middle of the year, time it took for us there was having the 2737 SAD/MAD safety data. We've reported them today, meaning that has come out. So there, we are exactly on time. So while we've changed plan is that it's a multi-country trial. And we've been discussing extensively, internally, with partner AbbVie as well, and felt that the risk of getting complete opposite input from 5 different countries was too high a risk. So that we say, "Guys, take your time here, do it well, go to the biggest country, the one with most experience in terms of CF, is the U.K., and let's go for a scientific advice there, so that everybody's comfortable with how we write the dossier and the design of the study."
So trials in the U.S., as I said, they're now -- the FLAMINGO trial is the first study we opened in the U.S., so we have an open IND for the FLAMINGO, and we have a plan where we, for each compound, open INDs over the coming months. So meaning the combination studies -- I should have looked to the planning phase the requirement of the FDA, the finalized report adds to our -- the way we can develop, that adds 4 to 5 months, and that's why it's always late. But there is no reason why we actively stay and wait, so only we include the U.S. somewhat later. And we kick it off early in Europe. We say that the environment for early studies in Europe, a number of countries have specialized on that to really allow you to move quickly into patients and to -- and allow you to -- they grant you fast response times. You always get tough questions, but within 2 to 3 weeks, you'll get rolling. And so we've organized ourselves in such a way that we have all those documents available in the format that they require. And then in the second Phase Is, European studies have started, we start to prepare for the U.S., but for the Phase IIb, don't worry, we will be there. And there is an active plan to open all the INDs there.
We zullen ons geduld dus maar bewaren.