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Re: gdsgds post# 28232

Friday, 10/01/2010 11:52:30 AM

Friday, October 01, 2010 11:52:30 AM

Post# of 59551
The FDA's 510(k) review process has been cofidential throughout, and is confidential for all applicants throughout. Dean has provided general context about what is going on without crossing the line, just like he did with the most recent questions from the FDA. He described a general issue with the label last year, but we don't know what it was specifically, because he's not allowed to say. We knew about the 17 questions that were mostly repeats and basic mechanical and hardware questions, but he is not permitted to recite to the public what those questions were specifically. We knew generally about the Radiologist Report but he wouldn't tell us anything specific about it. He shared the same general level of information with us about the recent back and forth, i.e., couldn't open a file or two, and didn't understand why certain data that was not typical of 510(k)'s was included in the package. He has been as open as he can be, and for that I'm greatful. If you think he has been more specific about past questions, please show me specifically where he has done that. I'd like to see the list of previous questions that we know were asked by the FDA.

Also, we keep hearing that Dean is requesting additonal shares to raise cash, but nobody can explain why he hasn't touched the 125,000,000 authorized but unissued shares that already exist. His actions speak loud in that regard.

It is also absolutely 100% false that Dean refuses to allow any experts in the medical field or media to look at the product. We know that there are at least 5 NDAs signed by other major players in the industry so that they can take a detailed look at the product.