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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Post by overthelakeonlyon Mar 12, 2016 10:07am

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Post# 24651315

UNBLINDED DSMB

Don't forget that the DSMB did a trial specific analysis ( unblinded ) for the first 184 patients and they surely saw something good in results from patients with MODS>9. That's why they proposed the additional exclusion criterion. So I think that we will have probably very good results with the last and final 176 patients randomized. My estimate is 15-25% absolute mortality rate which is very good, I suppose, for FDA approval.

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