Gates Package — page 47

Casco, Tony (NIH/NIAID) [C] From: Lane, Cliff (NIH/NIAID) [E] Sent: Friday, October 17, 2014 9:20 PM To: Higgs, Elizabeth (NIH/NIAID) [E] Subject: RE: Geneva meeting Thanks - we can talk virtually any time over the weekend. The main thing is to make sure that you and Ed and Lu are aligned. As per your note I think it is fine to hold off on specifics and focus discussion on the Bayesian approach. For the discussion regarding placebo controls I am not sure the water is as clear as it was to me for vaccines. While it is my preference and I know the preference of FDA I am not sure there is adequate equipoise within the investigator community. As an aside we do have a commitment from ZMapp to receive product for a stander RCT. In my ideal world the first paring in the RCT would be SOC v.s ZMAPP. with 40 doses of ZMapp you can treat 40 open label trial not be sure of what you have done or 80 in an RCT and have a chance at determining efficacy. From: Higgs, Elizabeth (NIH/NIAID) [E] Sent: Friday, October 17, 2014 6:03 PM To: Lane, Cliff (NIH/NIAID) [E] Subject: FW: Geneva meeting is) Hi Cliff, You must be exhausted. I am available if you wa one. a I'm appeal to a return of the old number! My work cell is . I know you wanted to touch base with me on the Geneva meeting. Having looked at the agenda I don't see where we (the USG) are supposed to specifically present the therapeutics protocol design. It looks like generic study design presentations followed by discussion. May be better not to discuss specifics beyond the basic Bayesian adaptive study design and we are not in a position to share a specific protocol as all there are still many decisions remaining on the protocol. I have reached out to colleagues in Geneva but I haven't had a response, but hope they will follow up tomorrow. My travel is set including the Oct. 23 Vaccine Development and Availability meeting. If tonight doesn't work, we can talk tomorrow or Sunday. I'm flying Sunday night. Best Libby Original Message----- From: Cox, Edward M (FDA/CDER) Sent: Friday, October 17, 2014 7:52 AM To: Lane, Cliff (NIH/NIAID) [E]; Borio, Luciana (FDA/OC) Cc: Higgs, Elizabeth (NIH/NIAID) [E]; McNay, Laura (NIH/NIAID) [E] Subject: RE: Geneva meeting and we are not ina position to share a specific protocol as all the partners have not Just received agenda (in attached e-mail). -Ed