Replies to post #16260 on Grapefruit USA Inc (GPFT)

[bcatch]

Why would Dean want to take the chance in putting anything out there that may cause the FDA to ask more questions. Can't anyone see he's playing it safe, the main goal is to get FDA approval. Why would you want him to rock the boat at this stage of the game. Maybe because you don't have any shares and after approval you won't have anything to do or anybody to bash, there goes the paycheck. Dean has already said he's working on a video to show the 3d images, why don't we all relax and wait for the video, which should answer everyone's questions.

[IMGGorBust]

Did you literally just copy and paste this post from 6 months ago? Are we really going to go through this nonsense again?

There are images from the DViS, both 2D and 3D, all over the place. There is a 3D image of a hand on Imaging3's website. There's a video at the top of this page from the RSNA showing 2D and 3D images. There are multiple videos on the Imaging3 website that show images from the DViS. If you make an appointment to meet with Imaging3's director of investor relations, they will bring you into their facility and show you the machine generating images in live time.

Dean has said he was reluctant to post any NEW images on the website because NEW images on the website would constitute new marketing materials for the device. He is 100% correct that it would constitute marketing materials. The FDA evaluates marketing materials when it reviews 510(k) applications. Putting out something new, without express approval from the FDA, would be utterly stupid. It won't upset them, but it will almost certainly delay the approval, because they would have to review the new materials. Why do it just to stop some whining?

Dean said that he would ask the FDA for the greenlight to post certain new images. If he gets that greenlight, all the better. It sounds like from GDSGDS that maybe Dean has that greenlight. If so great. If not, I'd rather just get the approval and see the new images later.

[BennyJ]

Why would the FDA care if you posted images from a device you are working on?

Due to last few years of RSNA conference appearances, awards(Frost & Sullivan award and others) and other events, DVIS Dominion created huge pent up demand in the industry. There are hundreds of orders already lined up waiting for the fda approval news. Due to huge demand & orders Dean has to stop accepting LOI's too from the interested parties. NDA(non-disclosure agreement) is also in place with Big boys for the buyout offer. Dean has already stated in many occasions that he has to stop accepting the LOI's since he should not suppose to market the product before the FDA approval. Dominion has been going thru' delayed approval process for stupid reasons(labeling issues, Division Device head change/reviewer change, requesting radiologist review comparison...). Dean does not want to pursue any single incident which can delay the clearance process further. He has been cautious now & He has to be like that since as a CEO of IMGG, his first & foremost priority is fda approval. nothing other than that.

Do a quick google search on "devices awaiting FDA approval" and you'll see everybody is posting information, images and videos of the work they are submitting.

Every product/company case is different. it could create a red flag in the eyes of FDA or may not. It is better to be on the safer side. Bashers/panic investors/shorters always find a reason to create panic by one way or other. If the images have been shown, they will find some other reason to bash. so it does not matter.

In previous conference calls Dean had tlaked about how he would post the images "soon." NOw all of a sudden the FDA will not approve because images of what it does are being shared with potential investors.

I remember he said in one of the conference calls which happened way back. Before the last 2 re-submissions. Since FDA asked for the AI, he does not want to do anything which could potentially stall the clearance process. Hope these answers help.


peace

jp