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Re: BennyJ post# 24373

Wednesday, 08/25/2010 3:07:38 PM

Wednesday, August 25, 2010 3:07:38 PM

Post# of 59551
bennyj... Yes!!! I connected these dots a while ago when I found breakaways 510k and compared it to the roadmap the FDA reviewer uses to come to a decision. Now we see how the new FDA team is handling the submissions that are waiting for a decision. They will not ask for more information when they do not think a 510K application has no merits, like they did with NEPH,They just sent out an NSE letter. I3 on the other hand was asked more question, multiple times and that to me is proof that the new team will be approving us soon since Dean has sent them all the info they need to approve the dominion. I would like to thank you for all your hard work and DD you post on this board. Can't wait till sept.8!!!