Grapefruit USA Inc (GPFT)

[DAK424]

Does everyone here understand what happened last year with the old review team? The old reviewer and her boss were responsible for dragging this whole process out over several years by nitpicking over every minute detail. They spent four months alone hammering Imaging 3 on mammography issues even though Dean had assured them that they already deleted that from their brochures and had no intentions of getting the DVIS approved for mammographies at this time! Every question had to be answered in writing and every answer reset the clock. That is the reason this has taken so long.

After a conversation with one of the FDA's Directors last year, Dean was assured that if he clarified his "intended use statement" his device would undoubtedly be approved. Please tell me, how could anyone have known that shortly thereafter that specific Director, the reviewer, and her boss were all to be among those that would be terminated? The terminations, by the way, were a direct result of bribes and payoffs that had been uncovered by the new head of the FDA which leads me to believe there is nothing nefarious going on behind the scenes at this time. In light of the terminations, the new personnel will no doubt tow the line for at least the time being. The 3rd party radiologist review was requested by the NEW team in order to make it easier for them to make a decision and approve the DVIS since they were coming in after the fact.

IMGGorBUST mentioned that he believes the new review team is treating this as a new submission and I tend to agree with him. This means Imaging 3 is most likely not on a "fast track" and the 90 days (for what it's worth) would end (as Dr. Polk suspects) on, or around 7/23. That would be 90 days from the last written request on 4/23. I hope this helps.