That's an interesting point. I would note- in the company's defense- that you don't want to get to cocky making claims about how friendly the FDA is going to be towards you (NEU's open touting of Breakthrough Therapy) being a case in point.
So even if the company believes they can get an IND and then through a big folder on the desk and say "here's the data, give us an NDA *NOW*" they would be right to hesitate about making such claims to market.
I have no idea how common it is to go to the FDA with a product that's already on the market. Maybe I should try submitting an IND for chicken soup.
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