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acm

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Alias Born 10/16/2009

acm

Re: gdsgds post# 16243

Wednesday, 05/19/2010 8:15:36 PM

Wednesday, May 19, 2010 8:15:36 PM

Post# of 59551
Sounds great. My only question is...

Why do 3d images jeopardize submittal, but 2d images don't? I have heard 3 stories on the 3d images 2 from Dean on the conference calls/videos, 1 from Mike Nessen by way of recon:

1) Showing them will jeopardize approval
2) They cannot be converted to a format which is easily displayed on the website or that laymen will easily understand
3) They are only available at a low quality and would not be sufficiently impressive

Did you get any clarification on what specifically about showing you the machine working in 3d mode would upset the FDA? I am really having trouble understanding that. I don't pretend to be an expert on the FDA and would love to be enlightened. It just sounds like a bit of a cop out.

I will be happy to ask on the forum if no one knows. Thanks for the info.