CBER / Novartis / Intended Population(s) Novartis Vaccines and Diagnostics Inc. / USA 6 Statistical Review / Lot 2 Group / rMenB+OMV Group / MITT / Per Protocol Set / Sex - rMenB02 Group / /
Country
Poland / United States / Canada / Australia / United Kingdom / New Zealand / Chile / /
Currency
pence / /
Event
FDA Phase / Business Partnership / /
Facility
Princeton University / University of California Santa Barbara / /
IndustryTerm
research organization clinical study report data collection tool / /
MedicalCondition
disease / invasive disease / serious and life-threatening disease / MnB meningococcal disease / available disease / B disease / B diseases / MenB disease / /
MedicalTreatment
active immunization / Vaccinations / vaccination / /
Organization
Office Committee / Center for Biologics Evaluation / European Union Food and Drug Administration / Division of Vaccines and Related Product Applications / University of California Santa Barbara / Date PDUFA Goal Date Division / FDA / Princeton University / European Union / Centers for Disease Control and Prevention / /
Person
Lot Numbers / P.H. Branch / S. Edward Wolfgang / Margaret Bash / Estelle Russek-Cohen / Dale Horne / Lot Consistency / Priority Review Reviewer / M.P.H. Anuja Rastogi / Concurrence Lihan Yan / /
Position
Team Leader / Project Manager / Director / DB Applicant Established Name / Major / Chair / representative / General / Chief / /
Statistical Review of Efficacy