you are making a lot of legal conclusions pushing this coming soon argument when you have no legal background and no basis to opine on how the FDA interprets these rules. You shouldn't be pushing these things with so much certainty when there is none.
if you were in a deposition a lawyer would cut this answer off in a second....non lawyer giving legal conclusion, lack of foundation, etc.
Let's not get aggressive in pushing another theory without a solid foundation to do so.
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