Grapefruit USA Inc (GPFT)

[alexdhcfx]

clarification of use,not a label

quote:
"Second, why did it take him approx a week to submit the clarification on the label? The step of labeling comes ONLY after the machine is "preapproved" by the FDA if it was not "preapproved", then why bother with labeling something that is not getting approval? Also, the labeling is, for the most part, an FDA approved marketing tool to use after approval. So think about it this way, I believe that the only reason Dean took so long to submit the clarification, which should have taken less than a day, is because he needed the extra time to contact the "potential" buyer for them to have there input as to what they wanted the label to say for their future marketing efforts"

It was not a clarification on the label, it was a clarification on the intended use, which is part of the approval process. Look at this chart for substantial equivalence.

This could mean that we are either going to be terminated as substantial equivalence (look to the right and see the intended use and how it leads to termination in the flow chart?

If we are moving to that of non-substantial equivalence then it will take much longer as they have nothing on the market to substantial equivocate to.

You see that is why we are not going up, it going to be a long wait and Dean should of never said that intended use was basically labeling. It is not, not at this point at least.
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