BLOO7 schreef op 13 juni 2019 00:33:
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4. Pushing harder for filgotinib
Gilead plans to submit for European approval of filgotinib in treating rheumatoid arthritis in the second half of this year. The biotech had hoped to also submit the drug for U.S. approval, but the FDA requested a safety study in adult males with ulcerative colitis because of concerns about testicular toxicity.
However, it sounds like Gilead is going to push harder for filgotinib. The company has requested a meeting with the FDA now that it has data from all three phase 3 Finch studies.
O'Day mentioned that he had been working with Gilead's leadership team on how the biotech could "accelerate some of the plans around filgotinib."It sounds like his conversations have made a difference. Robin Washington said, "We do believe there may be opportunities to enhance launch readiness for filgotinib that we are monitoring." Gilead Chief Scientific Officer John McHutchison stated that "there is some degree of urgency to get this drug approved as quickly as we can." That level of urgency didn't seem to be as great before O'Day joined the company.
www.google.be/amp/s/www.nasdaq.com/ar...Gezien de laatste ontwikkelen op clinical trials en de koers die een up swipe maakt de laatste weken denk ik dat men daar zeer succesvol mee bezig is.
De eerste lijn bij Gilead kan dat alvast al weten.
Hup Gala Hup.