Grapefruit USA Inc (GPFT)

[adrian taylor]

On April 2nd. 2008, the FDA advised Dean Janes that they would require CLINICAL TRIALS of functionality and imagery as part of the 510-K process. The FDA acknowledged this event by granting authorization to place the DViS out in the field.

But Dean Janes NEVER performed the critical trials. How could he possibly defy the FDA? There could only be one and only one reason why he didn't. THE DViS DOESN'T WORK. It is exactly the same reason why Dean Janes never showed investors functionality and performance. He certainly would have if he could have. It would have created such a boost for the stock.

Dean Janes was told last January by the FDA that they absolutely required the clinical trials in order to approve a 510K. His response was to immediately sell 2.6M shares for nearly $2M. The enormous delays that took place this year from time of submission was Dean Janes trying to skate around the FDA's insistence that a rotating radiation emitting device like the DViS required clinical trials that could never be provided because THE DViS DOESN,T WORK.

The FDA put an end to the charade by throwing out permanently the 510K. This was a very good move by the FDA as it forces Dean Janes into clinical trials. He cannot even file a PMA without firstly performing SUCCESSFUL CLINICAL TRIALS. But without a working machine, Dean Janes is now between a rock and a hard place, seeking out the help of lawyers to sooth the pain.