hi all, long time reader here.

great board, i've learned a ridiculous amount from all of you.

quick question for those with knowledge/experience of non-inferiority/superiority.

the tranche ii covenant regarding 171 is to show non-inferiority with a delta of .4% from the insulin aspart. I tried deciphering the fda's manual on non-inferiority, m1's, confidence intervals, p-values, way above me.

does this basically mean that afrezza with the next gen inhaler can perform .4% worse than the insulin aspart and still receive non-inferiority from the fda? Is that a standard tolerance for new drugs? Pardon my ignorance in advance.

I didn't see a % for the type ii study for superiority, is there a standard % that it has to beat the placebo by to prove superiority? i've seen .5% reduction in a1c's thrown around as a figure, but not sure if that is going off of previous studies or an actual standard necessary to prove superiority for the fda for new drugs.

Probably looking too hard, at the end of the day i want to hear non-inferiority for i and superiority for ii.

take care all and happy early 4th.