Lama Daila schreef op 3 mei 2019 06:45:
Transcript Conference Call Gilead:
seekingalpha.com/article/4259400-gile...Meeting met FDA by midyear:
We'll be able to file in Europe in the second half of this year, and we'll go and have a discussion now with the FDA. We've requested that meeting where we'll sit down and talk with them about what we have in terms of data from the MANTA studies what we have in terms of our Phase III registrational programs and what we should do. And the time the time lines around that will play out during that meeting. But look I think it's important to us and Dan has brought this with his fresh eyes on the program recently is that there is some degree of urgency for us to get this drug approved as quickly as we can and obviously in collaboration with the regulators across the world.
A – Daniel O'Day
No, I would just -- thank you John. I would just add Brian that I think it's, yes I've been impressed by the profile of the product through all three FINCH studies and the consistency and the outcome and the results on both the efficacy and safety side. And knowing that rheumatoid arthritis patients are waiting for highly efficacious medicines that also have good safety and tolerability profiles. I think, we're looking forward to the totality now the discussion with the FDA. So we put the request for the meeting. We expect to have that meeting by midyear and we'll be looking forward to getting back to you on kind of the next steps. But we remain bullish on this and looking forward to bringing this as soon as possible to patients around the world and in the U.S.