The only reason I brought up the labeling issue was because the atmosphere was somewhat similar to where we are now. We all thought approval was imminent. Then, as you cited, we got a new CDRH. All I'm saying is that it's possible something else could come up (which might explain the wait). You yourself even said, "that should be it." I agree.
Bottom line is that no one knows when the FDA is going to render a decision as they seem to be operating on their own timeline.
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