PTIE - problem is, FDA only gave guidelines so they can resubmit. The real play is when they get acceptance on the submit, since this would mean more chance they approve the drug.
"In recent weeks we have worked closely with the FDA, said Remi Barbier, President & CEO. We appreciate their guidance, we understand their new requirements and we believe were now on track to make expeditious progress toward a resubmission of the REMOXY NDA."
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