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Friday, May 24, 2019 1:22:12 PM
A 25 word summary of the relevent content of that entire statement for you!
The FDA issued an AI letter. Every 510K filer gets an AI letter. Most get 2-3 of them. Some things in AI letters are bullskat, some are legit. It is accurate to say that when a 510K application is filed, the filer then prosecutes the application. Part of the prosecution is answering AI letters. "AI" stands for Additional Information. It doesn't stand for deficiency, or criminal intent, or some sort of FDA commentary on DECN stock price. Mr. Berman, the CEO, is amply qualified to deal with an AI letter. He also has industry legends as consultants, and good lawyers.
When you come in and take over the company, you can fire all of these people Mr. Berman retains, and proceed with the prosecution all by yourself. It is easy, right? When a filer gets an AI letter the FDA allows 180 days to answer. DECN took what, 30 days? Less?
Please stop spreading falsehoods.
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