I will try again, the dosing regime for an o/p HIV or m/m is not the same for critical patients. For example a septic patient with SIRS in the ICU who TBW is increased by 30% and previous history of DM. Do we continue to dose the same SQ dose of insulin? NO! Bioavailability, issues, changing requirements, they are immediately placed on IV with continues glucose monitoring. Precision medicine. Not sure why FDA said "no", could be how the proposal was made. It is well known blood is shunted due to acute phase reactants, the use of vasoactive amines from peripheral blood sheds to the central organs. Principles of critical care medicine. We also avoid oral meds for the same reason that gut blood flow is shunted and the brush border is gone after a couple days.