Diary Prequel Package — page 438

to determine safety and efficacy. We are convinced that the Guineans would go along with the best scientific approach. Yet, WHO is trying to block the initiation of our trial until they have finished their trial that everyone with any sense knows that the ring trial will be inadequate. This is "politics" at its worst. Marie-Paule should really be fired. If we were the type to leak this to the press such as to Jon Cohen or Kai Kupferschmidt from Science, this would be a scandal for WHO. Finally, in the arena of incompetence and politics, the "Favipiravir study" in Guinea done by MSF and the French is claiming to show that it works (see above) even though there is no control group except an "historical control". Now the French are telling us that the Guineas are making Favi part of their standard of care (SOC). Thus, is we want to extend out ZMapp study to Guinea (where there are infections), then we would not be able to compare SOV versus SOC + ZMapp as we are doing in the USA and Liberia, and now Sierra Leone. The FDA and we feel that FAVI should not be SOC and if fact might be harmful. We will try to work with the health and political types in Guinea to get a proper ZMapp study going. Truly amazing politics, ignorance, and LACK of INTEGRITY on the part of people including people in WHO. MSF just does not know much about doing clinical research, even though they are "heroes" for their clinical care work. March 28, 2015 - Unusually cold, clear day for Spring in Bethesda. Around 28 in the AM. Patient continues to do well. Still hypomanic and not getting any sleep. We are reluctant to medicate him too much due to concern about prolonged QTC. Cliff and I continued our conversation by phone with Yves Levy in Paris and us in Cliff's conference Room on the 4th Floor of the ACRF in Building 10. Yves now agrees with everything that I indicated in note from March 27 (above). He will work to help get the RCT done in Guinea and we will work together with the RCT therapy trial in that the French will try to do the SOC + FAVI Versus SOC+FAVI+ZMAPP and we will do SOC versusSOC + ZMapp. March 29, 2015 - Sat up about 45 minutes with today (Sunday - sunny but very cold for end of March in DC - 23 degrees F). Continues to improve markedly. Moving all extremities well. Left arm issue resolving. Conjunctivitis improving. Sitting up and eating progressive diet. Speaking every day with his mother and friend who come up from Houston where he lives. We are considering changing status to "Fair". Of note, we still get very weak PCR signal from sweat, saliva and urine one or more of which alternates on different days from weakly positive to negative. This will have implication for his release and for broad policy given that the Liberian woman got infected (and died) from her sex partner who was an Ebola patient in the 100+ day of recovery. Interesting to see how this will all play out. March 30, 2015 - getting much better with strength and neuro approaching normal. Still too weak to get out of bed, but can stand for 1 minute. Eating voraciously; maybe too much since he has been having Gatorade, pizza, ham sandwiches and actually vomited. After this he felt fine. Have upgraded his condition from "serious" to "fair".