Gates Package — page 59

have any questions which we should consider. Thanks!! Jean From: O'Rear, Julian Sent: Thursday, July 24, 2014 07:51 AM To: Hu-Primmer, Jean; Roberts, Rosemary; Leissa, Brad G; Mullick, Charu; Miele, Peter; Donaldson, Eric; Choi, Su-Young Cc: Armstrong, Kimberly; Maher, Carmen Subject: RE: today's Ebola MCM working group Eric's document is not relevant here as there weren't any good candidate drugs for MERS-CoV so we were starting from square 1. I've attached my thoughts on the proposed candidates. Most of the information is in the public domain (links to references included). Jules O'Rear, Ph.D. Lead Clinical Virologist FDA\OMPT\CDER\OND\OAP\Division of Antiviral Products From: Hu-Primmer, Jean Sent: Wednesday, July 23, 2014 8:46 PM To: Roberts, Rosemary; Leissa, Brad G; O'Rear, Julian; Mullick, Charu; Miele, Peter; Donaldson, Eric; Choi, Su-Young Cc: Armstrong, Kimberly; Maher, Carmen Subject: Fw: today's Ebola MCM working group FYI....see email below RE the non-disclosure agreement. To extent that we can provide any comments on the "frontrunner" MCMs indicated by our HHS partners including what data gaps need to be filled before we would consider use for US troops/CDC EIS officers and other US citizens in affected areas, that would be great. I understand that those MCMs are: 1. MappBio's ZMab 2. Toyama's T-705 3. Biocryst's BCX4430 4. Unither Virology's UV4 (which is listed in clinicaltrials.gov for a dengue therapeutic study) Any thoughts on these specific therapeutics would be great to include. Gary has already sent an email to the lead POCs of each agency/institution that says we cannot share our document until we have everyone who is participating in the WG sign off on the MOU's NDA. Rosemary - I passed on your suggestion of looping NIAID/IRF into the discussions; I hope they will comply. Thanks all for your participation and help in today's discussions!! Jean From: Hu-Primmer, Jean Sent: Wednesday, July 23, 2014 06:25 PM To: Disbrow, Gary (0S) QIINOtns.cov) <I his.cov> Cc: Maher, Carmen Subject: today's Ebola MCM working group