Barbet01 schreef op 8 april 2021 07:42:
Is Gilead still interested in gaining US market approval for Filgotinib in IBD indications?
Yes, we are still exploring filgotinib in IBD indications. Of note, we will only move forward in the US market for IBD indications if we believe there is a best-in-class profile.
Manta outcome: is Gilead able to file for Ulcerative Colitis soon?
Pending additional MANTA and MANTA-Ray data readouts, we look forward to discussions with the FDA to help determine the best path in the US.
Isn’t there an option for Gilead to sell US rights for RA low dose to another firm (like Pfizer or so)?
Based on results from the FINCH trials, we believe that a 200mg dose is required to be competitive in rheumatoid arthritis (RA) in the US. As such, it is not clear yet if a low dose would be compelling for the US market.