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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

Comment by mercedesmanon Nov 09, 2023 8:17am
138 Views
Post# 35725561

RE:RE:x sites, y patients, always underwhelming

RE:RE:x sites, y patients, always underwhelming

Totally agree. 

Stoppage possibility once results are published. 

(small correction - this is not at midpoint but 90 of 150 (=60%). Or if you include Euphrates patients that met the Tigris criteria ( which is called for) more like > 80% complete. 

But you are also correct that the "confirmation" in this "open" Trial  could become compelling at 100,  110 or 120 requiring any keen observer including the FDA, to draw an inescapable conclusion at any time after 90. 

Finally there is every possibility that the FDA or that Spectral insists on achieving the full 150 ... however...

... there is nothing that says that Baxter won't pull the trigger having drawn their own conclusions about the inevitability of the final results after a deep dive post 90.  At which point they could simply marshall the trial to the end themselves.

MM 
 

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