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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 Jun 14, 2024 3:08pm
185 Views
Post# 36089747

RE:RE:RE:Fitch Ratings

RE:RE:RE:Fitch Ratings

Agreed ...,pure spectralation...

But one just never knows. 

KOLs Walker and later Kellum were hired, by a major Japanese conglomerate, to run Trials and get this across the finish line, with the hope of opening up the worlds biggest and richest market ( North America) for their already proven/ accepted product ( in Japan and parts of Europe) 

They also foresaw the need to have a companion diagnostic as the world moves towards precision medicine ( particularly for the more difficult diseases like Sepsis) Fortunately Walker had sought and obtained FDA approval for the EAA years earlier.  And to develop a diagnostic now it is prohibitively expensive ( and will achieve no value/purpose without an associated FDA approved treatment) 

The next requirement beyond FDA approval for PMX was securing a distributor. Mission accomplished in Vantive/Baxter ( no matter what happens wrt. PE)

This 20+ year exercise will have cost Spectral about $100M. A bargain by comparative drug/device standards. ( nowadays it costs $1B and up for new treatments requiring FDA approval) 

So now, in return for proving out the combo ( diagnostic and treatment) , locking in a distribution agreement and thereby successfully opening up a new, annual $2B USD market, it's time for someone, or more accurately some group of believers, to be rewarded. 

And really, who needs another middleman anyway?

Perhaps that's why there has never been any descernable movement towards a US public listing?

As I said, all pure Spectralation. 


glta 


MM 

 

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