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Re: ANTman2015 post# 13383

Monday, 04/12/2010 12:32:58 PM

Monday, April 12, 2010 12:32:58 PM

Post# of 59550
As I said before, the pre-approval move will not be because of the administerial act of submitting the package, it is because of what was in the package for the first time ever. Dean has not commented about it yet, but the fact is, in that package was an unequivocal endorsement of the quality of the DViS images and the function of the DViS device by at least one, and probably two independent, expert radiologists. While it was a huge pain for the Company to go through the process of putting together the Radiologist Review for the FDA, I believe the FDA did us all a huge favor by asking for it because it answers so many questions about the device.

I would like to see Dean offer a little bit more information to the public about the Radiologist Review now that it is completed, and obviously held great news or it would not have been included with the package. But that fact is what should drive us up big time even before approval.