Replies to post #46363 on Grapefruit USA Inc (GPFT)

[Denunzio36]

The FDA says so? Can you site where they SPECIFICALLY say that? And please do not use the NSE as a blanket response...you're better than that.

[KingKong_Guru]

Which line of NSE letter says that DVIS does not work.....

Apart for image comparison analysis everything requested was like clarification .....that is what people linked to FDA thinks ....

That were it is taking time to present effective image comparison protocol.

You said you contacted some FDA consultant and they say it PMA ........I bet this was the case ....

DVIS is 100% 510k .....a slight change in intended uses doesn't mean PMA .....DVIS is a NSR (Non significant risk) device ....

This was confirmed by many people who are linked to either FDA or IRB (Institutional review board).

Guys and gals: There are many radiology institution .....contact those people and explain what you saw .....You will know what exactly you witnessed ....

As per one Guy:

"Invention of of cone beam CT had opened path for real time 3d imaging since last decade, but nobody thought of gantry computer - cart computer continuous geometry information message exchange to achieve real time 3d update .....IMGG filled a very broad patent to create real time 3d using cone beam system ,hence closing door for other manufacturer to enter into this space.

I believe IMGG will never ship any product post FDA approval ,they will be bought out for very handsome sum (minimum 600-700 M"

Believe or not ...DVIS is real deal .....


KKG

[Homer Simpson]

Wrong, the FDA does not say the DViS does not work. The submission was incorrect and incomplete. Now that the consultants are on board, the submission will be complete and accurate. There is only one possible outcome and that is FDA approval. The device does work. everyone who has seen it say so. Some of those who have not seen it do not believe.

[LipMode]

Everyone that went to the open house gave favorable reviews of what they saw. Real time 3D was displayed by Dean himself. Although the stock price does not reflect it, I think Dean redeemed himself in some way. At least the debate over the machine working or not is now over. Its hard to come up with an argument for the machine not working when so many witnesses say it did.