For reference only: It took eight months for The M
Post# of 72440
Posted On: 07/11/2016 1:01:58 PM
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: ?
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: ?
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