What a completely pathetic post. An FDA request for additional information, which is extraordinarily common, can be as simple as changing wording on the label, a la, the exact type of request the FDA made last time. What a joke, and how irresponsible to suggest that responding to an additional request could take a long time or could bankrupt the company.
We are in the same boat we were in in November. Dean and team will responsibly and efficiently respond to what may be some very basic and simple questions, and then we continue to wait for the FDA to do what we all know is inevitible... approve the DViS 510k application.
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