"171 met the non-inferior threshold."
Absolutely true. But 009 met the non-inferior threshold as well and the FDA still had questions.
http://www.news.mannkindcorp.com/phoenix.zhtml?c=147953&p=irol-newsArticle&ID=1197424&highlight
In May 2010 at the Bank of America Merrill Lynch Healthcare Conference, Al Mann stated that “the 117 trial is our response to the agency relative to the A1C issue.”
I agree that the FDA was about to approve this the second time around (before "the letter") but wouldn't the FDA have been looking at the more favorable 117 data at that point? If this is the case, will 117 data plus non-inferior 171 data be good enough this time around?
