Clinical development timeline of ASP0113 (TransVax) from product concept in 2002 to initiation of a phase 3 trial in 2013. Initiation of various activities is shown in blue diamonds; regulatory activities are shown above the timeline and all others below the timeline. Horizontal blue lines and arrows depict the duration of the indicated activities. Development activities that continued and/or were refined during clinical development are shown in rectangular boxes within the large dotted arrow. Abbreviations: IND, investigational new drug application; FDA, U.S. Food and Drug Administration; EMA, European Medicines Agency; GLP, good laboratory practices; QC, quality control; DS, drug substance.
{}