r66 schreef op 19 augustus 2020 13:48:
"The
FDA has requested data from the MANTA and MANTA-RAy studies
before completing its review of the NDA. The MANTA and MANTA-RAy studies are designed to assess whether filgotinib has an impact on sperm parameters. The FDA also
has expressed concerns regarding the overall benefit/risk profile of the filgotinib 200 mg dose."
"The MANTA and MANTA-RAy studies are fully recruited, with
topline results anticipated in the first half of 2021. Filgotinib is currently under review by regulatory authorities around the world. Filgotinib recently received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use, recommending marketing authorization for filgotinib in the EU for the treatment of adults with moderate to severe RA who have responded inadequately or are intolerant of one or more disease-modifying anti-rheumatic drugs."
Zo heel heftig en onredelijk klinkt het toch allemaal niet.
Het is meer dat men het er snel doorheen wil drukken. Maar als hier zoals "geanticipeerd" "top of line" resultaten uitkomen, lijkt me er niet veel aan de hand.