RE:Listening to castThese are not FDA reviewers. This is an advisory panel, there is one FDA rep but they do not get a vote, observer only. The FDA advsory panels advise the FDA, so they do not have final say on a drug approval and they can be overruled by the FDA.
They are often very difficult and pose very difficult and sometime harsh critizems of new drugs, which none the less get approved. They may be directing areas for phase 4 studies after market as well as phase 3, so I would not panic with their retoric or the tone of their discussion. Also you have to remember this panel reviews a wide range of drugs in its area and are not as expert in the files as FDA personnel are.