Friday, February 05, 2010 3:03:28 PM
•Dean stated they have answered many of the questions the FDA had, and I understand that the few remaining questions are basically non-events.
•Dean said during the CC that he is very happy with the new review team. I believe they had a conference call with them and answered many of the questions already. It sounds to me that they are able to confer with the review team now at will, rather than waiting for 30-60 day response times.
•Many investors want to see high res images on the web site. I would think that this is the least of their concerns at this time as they are busy preparing the submission to the FDA. I think Dean needs to concentrate on submitting the requested images, and then post them on the web site.
•Really the only significant issue that remains is the Radiologist review. Dean is currently collaborating with 3rd party radiologists to compare the DVIS to the predicate devices (fact) and It is my understanding that because the Dominion uses the same off-the-shelf parts that this is very easy to do. It just takes some time to put these things together.
These are all positive signals my friends, Not one shred of evidence that this will not be approved. GLTA!
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