http://pcibiotech.no/other-presentations/pci-biotech-ipa-july-2019_current-clinical-trials-in-cholangiocarcinoma/
►A formal interim analysis of PFS will be performed after approximately 60 progression events (per RECIST 1.1, estimated at 120 patients.
Dynamisk etikk komité! Ikke minst en formell avtalt! Håndverk 100% fra ledelsen i PCIB!
CONCLUSIONS
► The translation of PoP of PhotoChemical Internalization with gemcitabine from preclinical data to clinical PoC data was secured in the PCIA 202/12 trial
► There is a huge unmet need in the majority of CCA patients, i.e. extrahepatic
► The fimaCHEM PCI procedure can safely be incorporated in SoC treatment, also with two procedures
► The promising RP2D dose taken into the pivotal trial, with a mOS of 21.7 months, and the safety profile of PCI has triggered the now initiated pivotal trial in Europe, and is soon to be expanded to the US
► The pivotal trial, with an interim analysis that may lead to an expedited approval, was designed in alignment with the expectations of RAs
► First site opened in March and first patient enrolled in May
Dette er statement! …interim analysis that may lead to an expedited approval, was designed in alignment with the expectations of RAs.
Her jobber tydeligvis ekspertise hos PCIB. Regulatoriske og avtaler av ypperste klasse. Så er også data som er levert av PCIB til nå svært gode. Regulatoriske myndigheter har tydeligvis fått det med seg🥳