Go ahead and call me a nerd, but I think reading FDA advisory panel briefing documents is kind of fun. It's not like they have exciting plot lines -- although in Dendreon's
After reading the executive summary released yesterday for Abbott Laboratories'
The pivotal phase 3 trial was set up so that the XIENCE stent only had to work as well as Boston Scientific's
Much of the safety data that the FDA required was kindly provided by Novartis
The only real problem that the FDA has with the trials is that the complete two-year safety data isn't available yet. But the subjects that have had their stents in that long showed a reduced level of major adverse cardiac events, such as heart attacks. Even so, I think it's likely that the FDA advisory committee will likely give it a pass on the incomplete safety data and recommend the stent be approved at its meeting tomorrow.
Johnson & Johnson