1) i am NOT concerned about the finances (worst case Dean can sell some shares to keep the lights on)
2) i feel this will get approved and i feel the company will get bought out very quickly
I think it is absolutley commendable they had you in for a tour and answered your tough questions....they didnt have to do that...when i did the tour i saw the same things and came away with a great feeling...like i have said many times i STILL feel this will get approved and bought out...however i wont stop thinking PMA until approval is in hand
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.