Replies to post #32852 on Grapefruit USA Inc (GPFT)

[adrian taylor]

The only way the FDA would ever accept a re-submission of a 510-K is with attached sucessful clinical trial data. This "additional information" does not currently exist and would take a minimum of a year to a year and a half to complete and only if the DViS really works.

[Denunzio36]

Vibe - You think that this will bleed like last time? I want to think that with McDermott on board, and their approval of resubmission, PPS would either hold or slowly move up. Everything sounds only positive right now. A conversation with the reviewer at RSNA, meeting with FDA, McDermott / I3 (who will know how to conduct a productive meeting with the FDA) and a cleaned up package, I would think that things are looking decent. Although the chances of overturning are not in our favor, I think we may have a solid case if everything is fixed, and the face to face at the FDA will confirm that all criteria are met in the new package. I'm feeling good about this.