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

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Comment by davikingon Mar 11, 2014 5:35pm

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Post# 22310153

RE:So what does this all mean?/

What does this mean? How important is it?:
A sample size recalculation is expected to be performed and reported to the Sponsor, as well as any other recommendations. The EUPHRATES trial was designed to show a benefit in mortality between the treated group and the control group of between 10% to 15% at a power of eighty percent. The original sample size of 360 enrolled patients would be required to show a 15% benefit in mortality, while demonstrating a 10% difference could require up to approximately 700 patients.

Can someone explain in layman's terms, please!?

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