"AI" stands for Additional Information. It doesn't stand for deficiency,... "He also has industry legends as consultants, and good lawyers." Tell him to sue the FDA then (he'll lose!): https://www.fda.gov/media/71735/download Such an FDA request for additional information is known as a “deficiency.”
Please stop spreading falsehoods. What falsehood have I spread? This is not so much a case of the pot calling the kettle black, as the pot calling the refridgerator black!!!>>
The FDA issued an AI letter. Every 510K filer gets an AI letter. Most get 2-3 of them ...so you sort of agree with me that its not particularly huge news, either way? Neither particularly good, nor particularly bad? That all it means is that they have neither approved, nor rejected the regulatory submission? ....which was kind of the point I was actually making?
Market Data 
Markets 
AI
