I will say this, nothing that happened prior to November 2009 has any bearing on where we are now. The entire CDRH transitioned. We have a new head of the department and a new reviewer. To say that "last time" they asked for a label change so we were sure we were done, and that didn't work out, is a meaningless analysis. It was a different review team that asked for the label change. That's like saying, a waiter is asked by a patron for a cheeseburger, and while the cheeseburger is being prepared, the patron gets up and leaves and a new patron sits down at the table, gets the cheeseburger and asks for something new and different. Well, it's a different patron, naturally he's going to ask for something different. That's the boat we're in. The new review team did a complete review of the file, determined that it had 18 questions/requests. The April 5 submission addressed each of those 18 questions/requests. A short time later, the review team had 2 minor requests for language changes. That's it. Barring another transition to a new review team, that should be it. Likewise, if we did not have the Fall 2009 transition at the FDA, we probably would have been done with the label change. That was just bad timing for Imaging3.
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