Spectral Medical Inc T.EDT

Alternate Symbol(s): EDTXF

Spectral Medical Inc. is a Canada-based late-stage theragnostic company advancing therapeutic options for sepsis and septic shock. The Company develops and commercializes a treatment for septic shock utilizing its Endotoxin Activity Assay (EAA) diagnostic and the Toraymyxin therapeutic (PMX). PMX is a therapeutic hemoperfusion device that removes endotoxin, which can cause sepsis, from the bloodstream and is guided by the Company’s EAA. PMX is approved for therapeutic use in Japan and Europe and has been used safely and effectively on more than 340,000 patients to date. It has pioneered the development of biochemical markers for the clinical syndrome known as septic shock. It is continuing its legacy business of manufacturing and selling certain proprietary reagents. It develops, produces and markets recombinant proteins, antibodies and calibrators. These materials are sold for use in research and development, as well as in products manufactured by other diagnostic companies.

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Spectral Medical Inc > The Euphas2 registry & really interesting data.....

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Comment by mercedesmanon Apr 22, 2021 9:00am

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Post# 33043466

RE:The Euphas2 registry & really interesting data.....

Good update STTom

so if I folly u correctly

Euphas2 registry offers up 120 patients that fall in the same EAA range as the Euphrates/Tigris optimal range (.6 to .9)

no safety issues

and that the overall results in Euphrates 2 are consistent with Euphas1 that was stopped early due to extreme efficacy

I don't see how or why the FDA could or would ignore this important data as and when it comes time to review the Bayesian Tigris, open label, confirmatory Trial.

MM

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