Ann: Additional Positive Patient Cases - Special Access Scheme, page-16

Im still wondering how they ever do phase 2 trial on sepsis? Surely sepsis is a deadly and time critical condition. How would you do a double blind placebo controlled trial there? I can only sssume it woukd be similar to vax trial where it is compared to best available current treatment? Even so theyd have to get approval from a patiend or family to give trial drug to someone in danger. Would be interesting to know how they plan to do this. Phase 1 relatively easy on healthy volunteers but phase 2 with actual sepsis. I am thinking first actual treatment of a sepsis case might also appear under the SAS scheme??