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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 15, 2021 9:39pm
164 Views
Post# 34129942

RE:Corporate Update provides new language RE: Tigris efficacy?

RE:Corporate Update provides new language RE: Tigris efficacy?

A very wordy yet important post there Tom. 

Allow me to carve out, and repost the most relevant bit 

"On Friday the disclosure on efficacy changed from "in-line with Euphrates" to "in-line with our expectation".  What a swell way to share knowledge of the OPEN LABEL phase 3B and not really provide any intel at all ; - )  The real question is around "expectation",  given PMX achieved 21% absolute efficacy in the phase 2 Euphas trial ( stopped early due to unexpected extreme efficacy ) AND we achieved the very same 21% in a 59 patient subgroup within the phase 3 Euphrates, what is "expectation"?

With all that they have learned in two decades,  I would have a Euphas like, or at least Euphas Registry- like expection myself ...and, the last time I checked, the Euphas Registry is being spear-headed by likely the worlds # 1 seeded Sepsis authority - none other than Claudio Ronco ! 


Im sure none of this ( ie other key RWE) will be lost on the FDA , who have also been watching the many other favourable, non-sepsis related studies and uses for Toratmyxin 

But before going there, Interesting that JL Vincent and Ronco believe strongly that in order to lick this problem ( Sepsis) that the FDA needs to look beyond RCT and mortality as a primary endpoint - and focus not just on RCT data, but also on the growing mountain of other data. 

With that one would be remiss not to include PMX studies where PMX is used to treat Covid patients  

700,000 Americans have perished so far from Covid...hopefully more treatments are on the way . 
 

Soon I will post a listing of some of those studies that suggest many other critical & valuable ( non-Sepsis) uses for PMX. Over and above studies showing positive results for certain Covid patients  

Who has the NA rights for PMX, not just for PMX as it relates to Sepsis ?

Anyone? 


MM

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