FDAnews
www.fdanews.com/articles/159599-achaogen-fda-agree-on-spa-for-phase-iii-antibiotic-drug-trial

Achaogen, FDA Agree on SPA for Phase III Antibiotic Drug Trial

September 30, 2013
Achaogen and the FDA have come to an agreement on a Special Protocol Assessment related to a Phase III trial for plazomicin in patients with gram-negative infections that are resistant to multiple antibiotics.
Drug Discovery & Development Magazine