I believe the FDA is going to give GNTA the green light after reviewing these results.
“These data confirm substantial activity for tesetaxel as initial chemotherapy for women with advanced, HER2-negative, breast cancer”, said Dr. Loretta M. Itri, Genta’s President, Pharmaceutical Development, and Chief Medical Officer. “Based on aggregate data from our multicenter Phase 2 trials, we will be conferring with FDA to identify potential registration strategies for tesetaxel in breast cancer.”