We have retained sole rights to GPS and GPS+ outside of the Greater China area. The B-cells "helped" by the helper T cells produce antibodies to specific WT1 epitopes. AML most commonly affects adults, and its incidence increases with age. This was a statistically significant difference (p=0.0175). Certain newly initiated sites have taken longer than expected to be fully operational. Data from this Phase 2 clinical trial was presented in 2016. In this study, treatment was continued until disease progression or toxicity. This clinical study was initiated in December 2018. The tumor type currently being investigated is ovarian cancer (second or third line). Six of the eight evaluable patients are continuing to receive GPS plus pembrolizumab. The FDA will not approve a BLA without a REMS, if one is required. A decision from the Supreme Court is expected to be issued in spring 2021. The BPCIA is complex and only beginning to be interpreted and implemented by the FDA. Violations of the FCA can result in significant monetary penalties and treble damages. Unlike Medicare Part A and B, Part D coverage is not standardized. On September 26, 2011, we changed our name to Galena Biopharma, Inc., or Galena. We do not expect to generate revenues for many years, if at all. We currently have no source of revenues from product sales. A failure of one or more clinical trials can occur at any stage of testing. Consequently, we may be subject to risks related to operating in foreign countries. We have determined that we will not engage in further development of NPS. The full impact of these decisions is not yet known. Litigation may be necessary to defend against these types of claims. The market price of shares of our common stock has exhibited substantial volatility.
