The M&M "plain or peanut" sounds like a doctor to me??Aren't you knowledgeable!
Hey Dunc. It was rather "fortunate" that Spectral used biomarkers throughout the Trial. It would seem that after the fact, they were better able to identify the group(s) most in need of endotoxin removal (and the relationship to better clinical outcomes). Guessing the first part of the Trial established the lower end of the range, while the latter part identified the upper end of the range (and an important safety adjunct). Makes one wonder about the "mandated" protocol change back in 2015. (a no-no or a know-know?). Anyway. Sure glad the FDA is morphing towards personalized medicine in their future approvals. coincidently that is what all the Key Opinion Leaders (KOL's) on Sepsis and Nephrology and Critical Care, have been calling for. Ciao Mondo, Hello World (-wide rights) MM