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Re: tattooed post# 25575

Saturday, 09/04/2010 8:01:32 AM

Saturday, September 04, 2010 8:01:32 AM

Post# of 59551
Tattoo - The FDA sets "guidlines".. There is no rule/law for the FDA reviewer that he has to follow. It's just a guideline or in other words a target. As BennyJ has posted the link to the FDA's 1Q results for 510k was 100%. These results says something positive with regard to their effort to complete reviews in 150 days. They hit the target successfully 100% of the time in the recent. It's not a science so if we have to wait a bit longer so be it.
All that being said, I have conviction that we will get results from the FDA sometime this week. If we do not get an answer from the FDA I do believe that Dean will inform the shareholders as to the status of the review process.
Ultimately the ONLY question that you need to ask yourself is... Will the Dvis get clearance on this submission or not in other words will the Dvis get SE or not. Personally with everything we know including the Radiologist Reviews that Dean himself said were "positive" I would have a difficult time selling my shares at this point. We are soooo close to the verdict that I believe will be APPROVAL.

Good Luck to you!!

JB