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BigOwl47

07/22/10 9:40 AM

#20832 RE: pendragon8062 #20829

pendragon8062, That is exactly what I understood. Thanks for your input. The purpose of the resubmission was to clarify what was previously sent. It was not a required action, but a common sense action initiated by Dean to help speed the process of review along.
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Admiral38

07/22/10 9:58 AM

#20836 RE: pendragon8062 #20829

Pendragon:

Thanks so very much for this lucid explanation! We can all now gather hope that sometime in the near future (this year?), Dean will hear from the FDA that his device has been sprinkled with governmental holy water and we can all rejoice.
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shosforkids

07/22/10 10:16 AM

#20839 RE: pendragon8062 #20829

Pendragon,Thanks for the solid info!!
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IMGGorBust

07/22/10 10:43 AM

#20845 RE: pendragon8062 #20829

Thanks, pendragon. That is my understanding as well. He provided the reviewer a "road map" to speed along his final pass through the full package. The "road map" was necessary because the reviewer was confused about why certain types of information had been included... and the answer each time was that the previous insane reviewer had requested. This also goes to show that Dean was dealing with a lunatic in the previous reviewer.