That is what has changed. Not the words. Not the sentence structure. The context. The regulatory posture. The duration. The silence. The entire pattern of behavior now points to a single conclusion. This is no longer review. This is labeling.
To miss that is to assume repetition means stasis. But in regulatory timelines, repetition under silence is not drift. It is closure. The file is no longer moving backward. The next step is publication.
This is quite an elegant and long winded way to say absolutely nothing has changed and you have no idea what you're talking about, but thanks for clearing that up.
Just so I can bump this post and show you how ignorant you are later, can you please let me know how long the finalization of the label generally takes? It's a pretty simple element, so I would not imagine much more than a week or two, max. Is it safe to say that if, in a month, we don't have an approval announcement yet you were (unsurprisingly) dead wrong and you will come make an apology? If you agree to that, until then I will gladly accept what you are saying as truth and stop debating you.
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