Re: 175: I don't believe weight gain is a big issue and neither are hypos. This is because the comparator arm was not receiving insulin at all (orals only + Technopowder without insulin loaded on). Weight gain and hypos are an unfortunate side effect of insulin so this was probably expected.

The only concern I have is regarding the 009, 117, 171 data you mentioned.

009 A1C results weren't too hot (or at least the FDA thought something along those lines which had something to do with the first CRL). These issues were addressed in 117 which showed much better A1C reductions. Now A1C data from 171 comes in and it's about the same as it was in 009...

I suppose it's possible that even if the FDA has further questions about 009,117,171 they could still approve for T2. Anyone have any thoughts around this scenario? Would this be unprecedented?

Corrections welcomed as this story gets more complicated by the day and I'm always looking for someone to poke holes in my reasoning.