anyone not directly involved in the study or its' review who would pay their way and spend an entire day to speak for a minute on a subtopic of a subject that is known to be almost universally wanted is either crazy or more likely, a paid shill of someone or something trying to be subversive. Or worse. It would be great for someone to contact her and do an interview with the intent of why such interest and just who asked her to speak.
They understood the questions perfectly which is why some were forced to vote like they did. That's one of the major issues that will be sorted out behind closed doors. As far as Miami-Dade perhaps 2. they need to vet and choose patient advocates better.
This is the FDA. BEWARE. Exuberance is ok but don't get too carried away. They have been known to dig in when pushed. Even a casual appearance of bowing to pressure becomes a future integrity issue. The argument must be made that this is AA and different considerations are in play. That is Woodcock's card to play. Let's hope she plays it well. Hold your positions, look at options to add AND protect.. taking out a second mortgage is never a good thing to do. Invest within your means which translates into "if I lost everything here how would I live the next day"?
actually some thought needs to go into her actions though it is folly to think we can figure out what if anything it means. Though you can argue the hype going in is what made her feel being there was an administrative decision, loading the room with FDA officials was unique and unprecedented. Could it be she knew what Frakas was presenting was harsh and less than unbiased, for some wrong reasons, and she wanted everyone there to know that his was a personal opinion not the official FDA opinion. Could it be she knew the gallery would erupt if some balance wasn't obvious? Did she want the panel to know that the questions were framed to elicit a negative vote but that there was room for less stringent thought with AA drug candidates. Did she know that this Neurology Division was the only one not on board with Congress' directive to expedite not derail NDAs offered as AA drugs? Did she have to hear the public statements, particularly the doctors and scientists who spoke in favor herself so as to have conviction and ammunition to grant temporary approval? Did she in fact want to assure parents and patients that "it's not over yet" more properly stated"it's not over till I say it's over."
anecdotal evidence should not matter. Historical data should. Visible evidence in deadly diseases that have treatment drugs with safe profiles should. When it works don't deny, explain why. That is what science should be used for.