OK so all 18 that got approved did so without a panel. Maybe the interesting question is "How many went up without a panel and got axed?" If the answer is none then it looks really good. Does anybody know?
Advisory panels are conducted when the FDA needs a second opinion, in this case it's understandable why, because we have a clear path to approval. The FDA like our primary submission data, but wanted to see if the data would be consistent in a longer study. The data was consistent and resent to the FDA.