Spectral Announces Results of a Face-to-Face meeting with the U.S. FDA

- December 17th, 2018

Spectral Medical (TSX:EDT), a Phase III company developing the first treatment for patients with endotoxemic septic shock guided by a companion diagnostic, today announces the result of a favourable face-to-face meeting with the U.S. FDA. As quoted in the press release: Spectral has been engaged with the U.S. FDA in an interactive Q-sub process for … Continued

Spectral Medical (TSX:EDT), a Phase III company developing the first treatment for patients with endotoxemic septic shock guided by a companion diagnostic, today announces the result of a favourable face-to-face meeting with the U.S. FDA.

As quoted in the press release:

Spectral has been engaged with the U.S. FDA in an interactive Q-sub process for the design and format of the next trial needed to add to the safety and efficacy data from the EUPHRATES trial. With many of the U.S. FDA’s major concerns addressed, the Company expects to update shareholders in the near future with respect to the timing for the initiation of the TIGRIS trial. The TIGRIS Trial is expected to focus specifically on the population of patients that showed a benefit from this therapy in the EUPHRATES trial. TIGRIS is expected to be run exclusively in the United States, preferably in centres that enrolled patients in the EUPHRATES trial.

“Spectral has benefitted greatly from the guidance that the FDA has provided. We believe that, having implemented a majority of their suggestions, that the study will produce robust findings that will add important information on the use of PMX hemoperfusion, and support a potential FDA approval in the future,” stated Dr. Paul Walker, President and CEO of Spectral.

Click here to read the full press release.

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