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Re: blutique post# 28073

Wednesday, 09/29/2010 2:32:54 PM

Wednesday, September 29, 2010 2:32:54 PM

Post# of 59550
I am not going to explain again why I post here. Just say that I have earned the right to do so. You have to be pretty naive to believe that a 3+ year delay is the fault of the FDA. If the DViS was approvable, it would have already been by now. We heard all the reasons why the first review team was replaced but even after 2 years they did not approve the device. The new review team has been at it now for more than 180 days and they to are failing to "fly right through" the approval process as Dean has so often assured us. There is something wrong. Dean should inform investors before it is too late.