Additional Relevant Details DA) has designated NeuVax (nelipepimut-S), combined with recombinant granulocyte macrophage-colony stimulating factor (GM-CSF), as a Fast Track development program for the treatment of patients with early stage, node positive breast cancer with low to intermediate HER2 expression, otherwise known as HER2 1+ or 2+, following standard of care. Galena’s PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVaxTreatment) clinical trial is an international, Phase 3 study to evaluate NeuVax plus GM-CSF versus placebo plus GM-CSF to prevent cancer recurrence.