ive had sepsis in my family a few times, scary of course, and you bring up a good point...the inadequate structure of trial design means exactly that - too few sepsis patients at any one location means the trial would have to be done at hundreds of hospitals, which means the FDA gets to skirt yet another medical problem due to technicalities and bureaucratic BS. they are not in the business of helping people. they are in the business of making money for BP. thats it. sepsis is a huge market that would make billions for the next breakthru. one huge problem i encountered was my father had suspected sepsis yet they had to wait for the lab to confirm it before medicating. why? because you dont want to give the strong antibiotics to someone who may not be able to handle the side effects, unless sepsis becomes the bigger problem. so you have to wait. and maybe too long, which is what happens often. we got lucky but a new breakthru drug that had little to no side effects could be given earlier as there would be so little risk and only reward in doing so. give LL today and when lab comes back positive, double down with antibiotics tomorrow or the next day- yes it can take that long.