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Monday, May 03, 2010 1:01:56 PM
what i dont feel very good about is the FDA's ability to get their arms around the dominion....obviously they asked the the Radiologist opinion to help them understand what the Dominion does
if the Radiologist opinions (there where at least two of them is my understanding) dont get us over the hump i fear PMA is in our future...
clearly the Dominions works, it does what it says it does....the problem here is the FDA doesnt understand it...if dean cant get them to understand it then the FDA is going to ask for field trials and a PMA application.
simply put the FDA doesnt understand the dominion and if we cant make them understand it they are going to ask to see it in action in the field...
Kimble
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