“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 we’re now on track to make expeditious progress toward a resubmission of the REMOXY NDA.”
This would be the resubmission following the third CRL for Remoxy six months ago (#msg-125388781). How long has this been going on? I’ve lost count of the years.