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BamaStang

05/14/10 1:59 PM

#15660 RE: recon #15658

Nice link.. Thanks Recon..
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investor_trader

05/14/10 2:23 PM

#15661 RE: recon #15658

Food and Drug Administration Approval Process:
Thanks recon for sharing the article on the FDA's approval process. Based on many years of interactions with other government agencies (specifically the EPA and FCC), I believe the author of this article is right on.
It's clear to me that IMGG has a superior product, which should have been approved by now.
Unfortunately, IMGG is a small company with very limited financial resources and no political clout.
There are bigger players out there that are clearly hindering/delaying approval of the DViS.
Although I'd love to see this new technology approved, I fear the FDA will continue to delay such approval until IMGG simply runs out of money and, once again, the shareholders are left holding an empty bag.
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ElHefe

05/14/10 2:59 PM

#15664 RE: recon #15658

Interesting article. A couple of items of note:

- "It cannot say, 'this is questionable, so do such and such and show us the outcome'."
And yet that appears to be what FDA did when they told Dean to send images and go out and comparable images from predicate devices and, by the way, include a review by a radiologist.

-Is the DViS being reviewed by an expert scientific panel of consultants as the article suggests is the norm? Are they not FDA employees?