The purpose of the End-of-Phase II meeting, which is expected to take place onAugust 31, 2017, is to review the Phase IIb results with theFDAand seek guidance from the regulatory agency on the clinical design and protocol of Oramed’s upcoming pivotal Phase III trial, in preparation for...
The final EOP2 FDA meeting minutes provided clarity to the Company as to the FDA’s expectations regarding key program areas related to pharmacokinetics, administration and use that should be addressed given the life-threatening condition that may be tre...
BioInvent International AB announces its novel anti-FcyRIIB antibody BI-1206 is progressing into the expansion phase of a Phase 1/2a trial for non-Hodgkin’s lymphoma, following a positive End-of-Phase 1 meeting with the US FDA. LUND...