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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
Post by somweyungguyon Oct 05, 2016 5:16pm
142 Views
Post# 25313982

The last 79 patients..were they "abdominally septic only"?

The last 79 patients..were they "abdominally septic only"?Below in black from Spectral..green from your truly..

The composite mortality rate of randomized patients in the trial since the protocol change has increased significantly and is now, on average, approximately 50 percent, which trend prompted the Data Safety Monitoring Board (“DSMB“) to recommend that the Company consider another interim analysis in order to recalculate the appropriate sample size for this specific patient population. By comparison, the composite mortality rate at the time of the planned interim analysis, conducted in January 2014, was approximately 30 percent.


This was written at patient 371, or 101 patients into the last 180.  In order to satisfy the reported 45% we finished with at patient 180, we would have needed to produce a CM of 39% on the final 79 patients or 30 additional deaths to accompany the 50 deaths on the first 101 patients.  If the placebo remained at 47.5%, our PMX group died at 30.5% and our absolute benefit is 17%.
Read more at https://www.stockhouse.com/companies/bullboard#5Gg4cqVx1wsVeQ6z.99
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