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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.


TSX:EDT - Post by User

Bullboard Posts
Comment by scroll4factson Oct 03, 2016 10:26pm
137 Views
Post# 25305173

RE:We dared to dream ........

RE:We dared to dream ........Right.  But we still don't know where this 18% comes from.  Is it the MB from a certain sub-group in the trial?  Also, is it possible for the FDA to compensate for or take into account the significant placebo effect before rending its decision?  Any possibility that this quick observational study becomes a PMS study?  What about the other beneficial treatment effects demonstrated across the multiple endpoints?  How much is worth a significant improvement in cardiovascular function and reduction in the use of vasopressors?  Finally, the big question is how much MB does the FDA need to give an approval knowing this a safe treatment providing positive benefits for patients in septic shock with no alternatives left.  How many lives have to be saved?


Bullboard Posts