i see this as positive. or at the very least, not negative. why try to show bioequivalence (as they are in the 30U study) to something that didn't work? aff1 results must have been as they expected or in the ballpark. so now, once that hurdle is out of the way (which was the only true hurdle per the fda for approval), mnkd is going to show how they can provide the same clinical results in a more cost effective manner for those requiring more insulin. once the 30U is approved, not only do you have just one cartridge instead of two, you have other combinations that cost less ass well using only two cartridges to get to 40U, 50U, and 60U. i don't have a clue how much TI is too much, but i can tell you that i've seen people on 110U of lantus and people on 10U of lantus- so there can be quite a range. same with big ranges and prandial insulins. but the take home point is if aff1 was not good, why do a bioequivalence study to it?