Gates Package — page 62

On Tuesday, July 29, 2014 1:53 PM, Mike Hensley <HOicloud.com> wrote: As discussed toward the end of the call today, I took a shot at combining the objectives of your phase 1 protocol submitted to FDA with the objective of separating the vaccine and ZMapp products into two separate protocols. See attached. I've done nothing more with the vaccine portion but I like Deb's suggestion of doing a vaccine study in Canada or as someone suggested today, in Geneva. Logical, since Health Canada apparently controls the drug product. In combining the two objectives I constructed an initial phase to be done in HCW's not yet deployed. In this group we can do the pK and immunogenicity work needed. Assuming we get reasonable data there we cold move into HCW's deployed and exposed. I could sympathize with a larger group in the first phase but was taking into account limited supplies of ZMapp when I made my choices. Some details I calculated from or extrapolated from your pre-IND package. Doses I chose based on the NHP trials. Once again this is a clinical synopsis but gives us a set of talking points and probably anticipates most issues. Lots of detail missing but easy to complete with a little q&a if this looks reasonable Mike Hensley [attachment "Revised Phase 1 ZMapp Study Protocol Synopsis jb ds(2).docx" deleted by Trina Racine/HC-SC/GC/CA]