A successful Phase1/2 trial of TSC in newly diagnosed GBM patients was completed in 2015. Subsequently, agreement was reached with the Food and Drug Administration (FDA) on the design of a single Phase 3 study that would support registration of TSC for the treatment of newly diagnosed GBM patients, in combination with radiation and/or chemotherapy. Discussion is currently underway with the regulatory authorities regarding design of a planned Phase 2/3 trial in pancreatic cancer. Both trials are expected to begin enrollment in 2016. A Phase 2/3 trial in brain metastasis is in the planning stages, with enrollment expected following interim results in the pancreatic cancer study. TSC has received Orphan Drug Designation for the potential treatment of GBM and brain metastasis, and expects to receive Orphan Drug Designation for pancreatic cancer in the near future.