Spectral Medical announced it has been engaged in an ongoing interactive review process with the FDA, after its acceptance submission for Toraymyxin.
Spectral Medical (TSX:EDT) announced it has been engaged in an ongoing interactive review process with the US Food and Drug Administration (FDA), after its acceptance submission for Toraymyxin.
As quoted in the press release:
Based on the filing acceptance date of July 20, 2017, the Company expects to receive more detailed feedback from the FDA on its PMA submission in the fourth quarter of this year.
Spectral also announced that a full manuscript has been submitted for review by a major international medical journal.
EUPHRATES trial results will be presented at two key medical conferences. The European Society of Intensive Care Medicine Conference (ESICM 2017 LIVE) will be held on September 25, 2017 in Vienna and will include an industry symposium promoting Toraymyxin™ sponsored by Toray Industries Inc.