Re: MannKind’s Afrezza Likely to Fail AFFINITY 1 Phase III Trial
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Apr 11, 2013 10:39AM
Edit this title from the Fast Facts Section
John Newman - Oppenheimer
Okay. And just one quick follow-up, in Study 117, it looks like you were measuring the change in Hemoglobin A1c from visit 5 to 14 and that was a 16-week study. It looks like in 009 study for Type 1, you were looking at the change versus the baseline. I am just wondering why you measure the change in HbA1c beginning at visit 5 versus beginning a visit say, one or two in that study?
Peter Richardson - Chief Scientific Officer
It’s a very good question. And it’s quite simple, in 117, we actually employed a running period. We wanted the patients to have the best fastening control. So, we are looking how we optimize the base. If you look at the FDA guidance this well-intensive, they tend to recommend (inaudible) diabetes. The 9 study which was designed actually sometime ago, I think one of the learnings was that we would have done better to how to run in period with that, and they are pleased that we chose to take our approach and that’s the reason for that comparison.
http://seekingalpha.com/article/202049-mannkind-corporation-q1-2010-earnings-call-transcript?find=009&all=false