Update: Human Genome presentation complete, addressed key concerns in FDA briefing without negative comment from panel. Currently on break, FDA will present next.
Update: Lunch break. FDA, as expected, focused on concerns. In my opinion, their use of pooled data from the multiple sub-studies fore safety concerns opens the door for HGS/GSK to point out that several of the secondary endpoints were statistically significant if the data is allowed to be pooled.
It’s the FDA’s job to consider risk, but benefits should also be viewed in the same light, as I see it.