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1. 2014-08-08 16:26 Anthony S. Fauci
   treatment of the returning American patients. o Emory University Hospital requested from FDA an emergency IND (elND) for use of ZMapp; one treatment course was shipped to Emory University Hospital o NIAID began toxicology studies on ZMapp to assist the DTRA project and support an IND submission e August 5, 2014 - FDA granted an elND to Emory University Hospital for use of ZMapp to treat the returning Ebola-infected Americans from Liberia. They each received additional doses on arrival. e August 2014 -- o DTRA exercises option on contract with Mapp Biopharmaceutical to develop ZMapp further in coordination with NIAD and BARDA o BARDA will award a contract to Mapp Biopharmaceutical for advanced development of ZMapp including optimization, expansion, & validation of product manufacturing, pivotal non-clinical animal challenge studies, and clinical studies towards FDA licensure e September 2014 - o Kentucky BioProcessing will commence manufacturing of ZMapp for Mapp Pharmaceutical under BARDA contract to support additional non-clinical and Phase 1/2 clinical studies o Additional manufacturing runs will occur to optimize manufacturing process immediately after previous manufacturing runs have been completed Tech transfer of manufacturing process to other tobacco-based manufacturing sites Mapp Biopharmaceutical with DTRA, NIAID, and BARDA will meet with FDA in a pre-IND. meeting to discuss data and any outstanding questions or concerns e Anticipated December 2014 -- Mapp Biopharmaceutical will release ZMapp for Phase 1 clinical study e Anticipated January 2015 -- Mapp Biopharmaceutical will submit IND to FDA e Anticipated February/March 2015 -- NIAID will initiate Phase 1 in healthy adults in U.S. and Phase 1/2 clinical study in Ebola-infected human subjects in West Africa BioCryst -- BCX4430 antiviral drug e September 2013 - NIAID started funding BioCryst (Cary, NC) for early development of BCX4430, an adenosine analogue, as an antiviral drug for treatment of Ebola infections in September 2013. e August 2014 - Biocryst completed initial studies with product candidate in a murine Ebola challenge model and developed a pilot scale product manufacturing process e September 2014 -- o USAMRIID will evaluate the efficacy of BCX4430 in NHP challenge studies with Ebola virus. o Biocryst will commence manufacturing of BCX4430 for clinical trials. Manufacturing could be scaled up to 5kg from current 1kg if warranted. e Anticipated November 2014 -- Biocryst will make available 10 treatment courses for clinical

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