For reference only: It took eight months for The Medicines Company to reach a SPA agreement with the FDA. Both Oritavancin and Brilacidin are single-dose treatments for ABSSSI with QIDP designation.

Oritavancin SPA application date: March 26, 2010

http://www.accessdata.fda.gov/drugsatfda_docs...00MedR.pdf

Oritavancin SPA agreement date: November 30, 2010

http://www.firstwordpharma.com/node/809053#axzz4ABcs9svI

Brilacidin SPA application date: February 26, 2016

http://cellceutix.com/cellceutix-submits-spec...VzXCm.dpbs

Brilacidin SPA agreement date: ?