Eeven een paar quotes uit de Gilead 2q19 webcast transcript:
Daniel O'Day,
"We will also be filing in the EU really eminently at this stage"
Dan vermoed ik dat we eminently moeten vervangen door Imminently.
Letterlijk een dezer dagen dus.
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Umer Raffat
Hi. Thanks so much for taking my questions. I wanted to focus on two pipeline programs, if I may. First on filgotinib, so based on everything disclosed so far in the pool data, there is no DVT imbalance, and that's very important. But my question was, what about all thrombotic events? So, for example, the retinal vein occlusion in France too was technically not a DVT. So, what about all thrombotic? Is that still no imbalance at all? That's point number one.
And the second one was on the Galapagos IPF program, we know the Phase II trial there ran -- had a meaningful baseline imbalance on FVC median. And my question is have you analyzed the FVC data on similar sets of FVCs on the placebo arm versus the active arm? Thank you very much.
Daniel O'Day
Thank you, Umer. So, we're going to get John involved here. John, Sundy so, thanks John.
John McHutchison (klopt niet dacht ik, die was er niet bij)
Sure. So, first of all to start off with filgotinib, getting to the issue of -- issues across all thrombotic events, we are still very pleased with the results across all those events, and don't really see anything that would change our perspective on that compared to the specific data that we've presented already.
Moving on to the Galapagos compound, as you might imagine, we looked very carefully at all of the available data in the IPF program. We have quite a bit of experience in IPF ourselves with prior programs at Gilead as well. And we saw that the data really provided the confidence to Galapagos to be able to move ahead and we share that confidence with them.
Eerste paragraaf, de 52 weeks resultaten liggen ongetwijfeld al in de tas en dus in lijn met de 24w. Zullen de 52w data worden gepubliceerd bij indiening EMA ?
Tweede paragraaf, toch weer lekkere bevestiging van andere experts mbt het IPF programma.