Replies to post #14628 on Grapefruit USA Inc (GPFT)

[Lambster]

Is this something that typically happens Kimble? Not that it would scare me away, but obviously would take more time to accomplish. Honestly even that scenario is very promising. To have the FDA say yeah it all sounds great, but does it actually work? And then after witnessing that it in fact does as advertised....KABOOM. The question is, how long would that process be?????

[docmts2]

Is it the "supplemental" info Mr. Janes said he sent that has you worried? I personally thing a PMA would be ridiculous in this case and I'm convinced that the 510k is teh right application under which this device should be filed. But the "supplemental" statement stood out in my mind as more info that would take more time for the FDA to examine. Hopefully I'm just being paranoid and this is just the FDA being thorough, hopefully in a timely manner.

[IMGGorBust]

Talk about rank speculation. Where in the world are you getting that the FDA doesn't understand what the DViS does? They get that it is an X-Ray and CT device that offers 3D images in real time. They had some question as to whether it could generate comparable images to both an XRay and a CT device in its various modalities. That's why they asked for the Radiologist Review, and the Radiologist Review no doubt addressed that question. The fact is, as stated by Dean on the last Conference Call, the FDA has never even uttered the word PMA and he believes there is no chance we head down that path. It's not been discussed and the types of questions that have been asked, confirm for him, that it is not a possibility. I will trust Dean's opinion, who is having frequent interaction with the FDA, over this speculation of yours any day.