egeltjemetstekel schreef op 3 mei 2019 15:24:
seekingalpha.com/article/4259526?sour...Quote:
"Getting filgotinib in gear
O'Day waxed rhapsodic about this JAK inhibitor, which has completed three Phase 3 studies for rheumatoid arthritis, with other autoimmune disease indications being studied. He is not taking the male fertility issue - a question raised by an animal study or studies - lying down. He is insisting that an EU filing be done ASAP, i.e. in H2 this year. As far as the FDA, the company will meet with the FDA ASAP as well to discuss next steps. I would expect that the CEO will want to be present for this meeting. GILD will argue that filgotinib may be best in its class, and that most cases of RA are in women; and that in men, many are beyond child-bearing age anyway. O'Day made it clear that time is of the essence in launching this important product for RA."