"While she basically hides behind the fatal-flaw=primary-endpoint-failure axiom she does ask why the 80 day endpoint isn't just as important. Overall she does seem to have some positive inclination but can't get beyond the headline failure."
IMO it was more that the FDA couldn't get behind the primary endpoint failure. Read the two FDA reps response when the question was raised about whether 80 days is just a more mature version of 50 days. They wouldn't answer. They just said there was no alpha left, and there concerns were broad, not just about the 50 day failure. That was the non-objectivity that disappointed me, and IMO was a reflection of the way the agency intended to handle the drug.
News 
Market Data 
Discover 
