Replies to post #32769 on Grapefruit USA Inc (GPFT)

[King Shaka]

IMGG led everyone to believe we were good to go with nothing more than a simple labeling issue. That is a fact. NSE would conclude that we had way more to worry about. That is a Fact. We have been down to around 5% of our highest value. We are barely hanging around 9% of our highest value. These are Facts. These Facts are undisputable. Ideas that there are problems at the FDA are opinions.

The King

[Dr. Mugs]

Kingfisher 7234... I understand what you are saying here, but what made the FDA take so long to make a NSE decision? Dean said in 08 that he might have to file a new 510k submission. That same year he asked the FDA for permission to do an IDE. The FDA gave him the go ahead but he never followed through with the testing. The FDA was most likely waiting for them to do the IDE and return the results. Moving foward, I do not think that a PMA has to be a death sentence. I would like them to find a partner, maybe toshiba since they are very interested in the tecnology. I was told they wanted to lease it after approval . So they do a brand new submission and since they will be going the PMA path, they should include the 4D heart beat and mamography since they were going to have to do a seperate 510k for those applications. Maybe I had too much wine and turkey, but I can still see a bright future for this company and the Dvis.