Jeg tenker at ingenting er avgjort her enda. Vi vet bare at dataene er “mindre” lovende, og det kan fortsatt være innafor? Hvis man leser pressemeldingen fra 2 juni:
As a result, the Board of Nordic Nanovector has decided to conduct a comprehensive review of all aspects of the PARADIGME study. In order to fully protect the integrity of the study an independent evaluation of the data collected to date has been commissioned and will be analysed by an Independent Expert Panel. This information will then be used to determine the best path forward for the study. PARADIGME will continue to enrol patients while the independent evaluation is ongoing.
Tror dere styret ville gått videre til FDA og de regulatoriske hvis data var ubrukelig? Nei. Da ville de nok ha tatt en PCIB “Decided to stop the study”.
Det kan også hende at komiteen anbefalte NANO om å henvende seg til FDA og de regulatoriske for veiledning.