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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

Post by mercedesmanon Nov 24, 2023 11:35am
241 Views
Post# 35751609

85% of the way ?

85% of the way ?Readers of Kellums last paper on Bayesian analysis in the context of the phase 3 (Euphrates) and 3b Trial (Tigris) understand that the results are statistically analyzed together ( with slightly different weightings for each ) and why we are likely 85-90% of the way. And the burden of proof is getting lighter and lighter ( see revised 7% ARR needed, despite an at expectation of 10% or more. Now factor in a exceeding expectation for the Tigris Trial and its no wonder that The Paradigm analysts is calling the outcome an all but foregone conclusion. This of course begs the question as to whether or not the FDA will insist on an enrolment of the last 60 (or 50, or 40) when lives are at stake, with an open label trial where Dr.s are neither blind to the effects of PMX, nor to the impact of this novel and proven treatment on their patients lives. MM
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