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Domingoakasunday

05/27/10 9:29 AM

#17238 RE: stokguru #17236

I think you may be reading more into this than there really is. The FDA will review any marketing materials out for the device, which could cause some issues, but it isn't that they will stop you from putting out information about the company or device before it's been approved.

I would guess Dean made the video, asked the FDA review team if it would cause any issues (since he says he's been in close contact with them, that shouldn't be an issue) and when they said no, he posted it. Approval can still come at any time, be it today, this week, this month or this year.
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prussian4profit

05/27/10 11:34 AM

#17246 RE: stokguru #17236

stok,

It is my humble opinion that the video and new images that we saw is proof that clearance is on the horizon. By that, I mean we will be getting a PR in the month of June if not sooner.

Dean has said more than once that the FDA prohibited the showing of any new images as they saw this as marketing a product that hadn't gotten clearance.

If you watch Dean in that video, he looks like he's trying to keep a huge smile off his face. His confidence was just beaming. It's a very different image of him since the word came back that the FDA needed more questions answered as well as the radiologist review.

-p4p
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mr_sano

05/27/10 12:35 PM

#17249 RE: stokguru #17236

IMHO the whole "rock the boat" with FDA is just "smoke on the water"
FDA may have some issue with marketing material if they blatantly making claims the device cannot support. Nothing a few well placed disclaimer paragraphs can't protect against. I still don;t get why Dean would show the blue beast in operation with it's innards exposed yet say that the offsite device is not being shown to protect against the competition prying eyes??. Whats the difference?The basic configuration is there.

Volume is drying up and I'm sure the hype will begin tomorrow to try to drive the PPS over the weekend. This is about as imminent as our sun going supernova.