BLOO7 schreef op 23 augustus 2020 16:52:
[...]
Eigenlijk zou hij het voor bekeken moeten houden.
Wie vertrouwt hem nog ooit?
Wie betrouwt Walid nog ooit?
2 juli 2019
Onno:
De FDA eiste een extra zogeheten Manta-studie naar de impact van filgotinib op de vruchtbaarheid van mannen.
Die voorwaarde valt nu weg. Galapagos en zijn strategische partner, de farmareus Gilead, krijgen groen licht om filgotinib in de Verenigde Staten te lanceren. ‘We kunnen het medicijn aanmelden bij de toezichthouder zonder te wachten op de afronding van de Manta-studie. De data waarover we nu beschikken, zijn dus genoeg’, zegt Onno van de Stolpe, de CEO van Galapagos.
De FDA eiste een extra zogeheten Manta-studie naar de impact van filgotinib op de vruchtbaarheid van mannen.
Die voorwaarde valt nu weg. Galapagos en zijn strategische partner, de farmareus Gilead, krijgen groen licht om filgotinib in de Verenigde Staten te lanceren. ‘We kunnen het medicijn aanmelden bij de toezichthouder zonder te wachten op de afronding van de Manta-studie.
De data waarover we nu beschikken, zijn dus genoeg’, zegt Onno van de Stolpe, de CEO van Galapagos.www.tijd.be/ondernemen/farma-biotech/...Walid:
door Lama Daila » 27 apr 2019 16:50
Donderdag (Gilead earnings call) zouden we iets meer kunnen vernemen over de pre-NDA-meeting met de FDA waar Manta (RAy) het kernpunt van de discussie zal zijn:
Christopher Marai -- Nomura -- Analyst
Thank you for taking the questions. Congratulations on the progress. First, just may be touching upon your pre-NDA meeting with the FDA. I was wondering if you could provide an update on that timing, has that occurred or is that still pending? I know it should be in the next month or 2. And then on that point, is there any updated thoughts that you could share regarding MANTA our MANTA RAY data in terms of the requirement for the submission? Do you expect that data to be required at the time of submission? Or that it may be possible to submit it just prior to approval? Then I have a follow-up.
Walid Abi-Saab -- Chief Medical Officer
Thanks, Chris. It's Walid. So I think we've already discussed this kind of strategy before and Gilead have also discussed this that once we have the FINCH data, which has occurred we will ask that in discussion with the FDA and based on the no-risk benefit that we've seen so far in the FINCH program and discussed with them the filing strategy and that's the pre-NDA meeting that I think you're referring to. We would expect that to happen in the next few months but we don't -- we're not guiding any specific date. Although there could be more information that will be shared by Gilead, I believe next Thursday, May 2 will be their earnings call. And I direct you guys to follow up there because there might be more information at that point.
And then just whether or not the data from the MANTA program will be needed for filing or not, again that's going to be the crux of the discussion. And so at this point it really becomes an opinion that I would have on this and so I think it's better not to speculate on it. I think we have concrete data right now that we have in the FINCH program and we have clear progress that we've made within MANTA program and clear commitment that we're doing these studies those will form the basis of the discussion with the FDA and we'll see based on that what the outcome will be.