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Spectral Medical announced the United States Food and Drug Administration (FDA) accepted its rolling PMA application for Toraymyxin (PMX) for review.
Spectral Medical (TSX:EDT) announced the United States Food and Drug Administration (FDA) accepted its rolling PMA application for Toraymyxin (PMX) for review.
As quoted in the press release:
The acceptance of the filing means that the FDA has made a threshold determination that the application is sufficiently complete to permit a substantive review. The Company will continue to work closely with the FDA to facilitate a timely process.
“The acceptance of this PMA filing for review by the FDA represents another significant step forward in our regulatory pathway towards potential approval of our personalized treatment for patients with endotoxemic septic shock. The incidence of sepsis continues to rise in North America with no specific treatment yet available,” said Dr. Paul Walker, President and CEO of Spectral.