I’ve got a lot of respect for you @RNClarke.....your not trying to down ramp by any chance??
Rap are submitting for a class two FDA...it’s not similar to a de novo at all, pck may not need to go down the trial pathway as stated in the Ann, they may accept the info we already have..
PCK are focused on the immediate commercial opportunities in Australia and Europe...
Training staff is timely and expensive??
The training videos have already been developed, at no cost to pck..as you know.
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I’ve got a lot of respect for you @RNClarke.....your not trying...
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