IIRC, I believe the concern was that the FF component didn't appear to contribute much. Everyone appreciated the benefit of VI. But FF/VI in combo was questioned. The FDA took a position a bit more favorable to the company than the panel did at times.
Compared to today's AVEO decision, this adcom was a pep rally.
Sono, it appears from the studies that just the opposite is true. The FF/VI combo was signifcantly more effective than the FF or VI alone. Placebo-Controlled Efficacy Studies
The first 24-week, randomised, double-blind, placebo-controlled study evaluated the efficacy and safety of UMEC/VI 125/25mcg, VI 25mcg, UMEC 125mcg and placebo. This study randomised 1,493 patients. For the pre-specified primary endpoint of trough FEV1 at the end of the treatment period (Day 169), this study showed statistically significant improvements for UMEC and VI individually compared to placebo (p
Yet the FF component, by its nature, is immunosuppressive, and more folks died unexpectedly of pneumonia. This is a multifactorial situation, FF alone was not the culprit. These people were more than likely very unhealthy, multiple heath histories very likely, but lets not rule it out altogether. This is indeed a very, very close call for approval. Don't kid yourself.
lol.....if you look at my history as a poster I am simply an inquistive mind wanting to know more. I don't get caught up in the shorting and pumping schemes. I am invested in this company and am hoping for approval. Upon checking the FDA decision of 9-4*, I did see that one FDA member intended to vote no, which would've put it at 8-5. I am just trying to gather more information that other members can hopefully provide.