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IMGGorBust

05/19/10 7:59 PM

#16244 RE: gdsgds #16243

How did the images look?

mr_sano

05/19/10 8:05 PM

#16245 RE: gdsgds #16243

200K in cash and your still not worried? They burn 140K a month!

kimble1

05/19/10 8:13 PM

#16247 RE: gdsgds #16243

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

kimble






acm

05/19/10 8:15 PM

#16248 RE: gdsgds #16243

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.

scottmba

05/19/10 10:12 PM

#16256 RE: gdsgds #16243

Thanks GDS. What do you mean by "public conference" and when was that?

hubris heyday

05/20/10 10:48 AM

#16298 RE: gdsgds #16243

Gdsgds, Thank you for these words. "Mike told me........

, they received two requests from the FDA , one requesting all docs on a disc and the other is change some verbiage in the manual."

If the FDA had all the "red flags" that some posters are suggesting they would not ask for these items.

I can see the FDA now...
you dont have any money (investors)
you dont have a machine (investors)
your machine does not work (investors)

by the way can you get us hard copies and change some verbiage the MANUAL so we can pass this this... (FDA)

The hard copies are for approval. Going back to the boat....
Have fun guys and girls.