Spectral to File Final PMA Module With the FDA for Its Toraymyxin™ Treatment of Endotoxemic Septic Shock

Spectral Medical (TSX:EDT) announced its plans to file the fourth of four modules of its premarket approval application (PMA) containing the clinical study report, with the FDA for Toraymyxin™ early in the second quarter of this year.
As quoted in the press release:

Over the last few months a thorough review and analyses of the trial data base has been completed with guidance from the Steering Committee. The information from the EAA measurements has been instrumental in the data review process and has led the Company to its strongly held belief that the Toraymyxin™ column is safe with clinically significant evidence of efficacy. Based on this data review and analyses, the Company has informed the FDA that it plans to submit its final PMA module early in the second quarter of this year, in keeping with the regulatory pathway en route to approval of Toraymyxin™. It is also the intention of the Company to release further detailed results of the clinical trial at a scientific meeting soon after the filing of PMA.
“We are very encouraged by the results of our analyses and the merit of our data. As such, we intend to proceed diligently with our regulatory program. Septic shock continues to claim a significant number of lives each year in North America and no other treatment is currently available for these patients,” stated Dr. Paul Walker, President and CEO of Spectral.

Click here for the full press release.