鉴于在我们的REVERT 1(HPV-301)中观察到的意向治疗(ITT)人群的结果VGX-3100的3期临床试验没有统计学意义,仅REVET 1和REVINE 2研究不太可能支持VGx-31000的上市许可。FDA表示,在这个选定的人群中进行一个或两个充分和良好对照的后续试验将更有可能提供足够的证据来支持VGX-3100的上市申请批准。FDA还指出,REVORE 1...
and our ability to successfully manufacture and produce large quantities of our product candidates if they receive regulatory approval. Actual events or results may differ from the