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prussian4profit

01/06/10 1:34 PM

#8099 RE: IMGGorBust #8098

Well put. Don't forget that this allows for revisions outside the medical field as well. By narrowing the intended use, they would have backed themselves into a corner and the additional paperwork for security application would be endless.

This would be the only 4D system for full body scan in airports. That changes the market cap just a little don't you think?

-p4p
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mx10001

01/06/10 1:59 PM

#8102 RE: IMGGorBust #8098

IMGGorBust, that is correct. The revisions did not limit usage so much as make categories of usage more general, as in orthepedics, pediatrics, etc. Some here, like Borntwice, think that we somehow drastically reduced the range of usage and therefore the inherent value of the Dominion. Completely wrong.
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kinlaw

01/06/10 3:40 PM

#8112 RE: IMGGorBust #8098

I couldn't have said it better myself. I'm happy to see someone on this board is using some common sense. I see people posting information such as "Dean submitting the wrong application", "GE/Toshiba conspiracy theories" and the whole gambit of reasons why this thing is being delayed and none of it is remotely close to the truth. This is the FDA people! They are not part of any conspiracy and the appropriate application was worked out between them and Dean a few years back. Do you really think Dean submitted the wrong application? Do you really think the FDA will ever take a chance, especially with this administration, to get caught up in some conspiracy, like getting bought by GE/Toshiba to outright delay a decision or deny a device such as this? Come on! Do you really? My advice for those that are believing this mess is to sell, sell, sell and move on to something else. For us Longs, we have completed our DD and have read the 510k process word for word; which is posted on the FDA site for all to see, and know that this was never a 30 day decision from last submission.