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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 May 24, 2023 11:07am
224 Views
Post# 35461882

Assuming the current pace is maintained....

Assuming the current pace is maintained....Assuming the current pace is maintained...of just 5/month ....

That acheives 90 in six months (30/5) or before the end of November of this year !  Interim data release is at patient 90 where Baxter decides whether to continue to fund the Tigris Trial (with another $ 5M? $ 10M? infusion).  One has to wonder why they would not, given results are (greatly?) exceeding expecttaions, and the fact that they have already put in $ 10M USD, the only Analyst assumes 100% liklihood of FDA approval, and thta baxter is featuring PMX/EAA in their KidneyCo teaser, and they are spending money on marketing materilals so that they can hit the ground running.

Assuming the Trail is not stopped at 90 (Spectral Mgt says it won't be...but I wonder how the FDA feels about it?) - when would the Trial finish - worst case ? 

If the pace stays the same and they go from 16 sites (current) to 25 shortly (paperwork in the works now) ...that's approx 8 per month (5 x 25/16) - which is the same current pace per site, just with more sites.

So starting in December, in order to complete the trial (150) at a pace of 8 per month (ie. an extra 60 patients) they would  need an additional 7.5 months.   That's roughly a completion by June 2024 !

Or if the pace picked up by say 2 per month (to 10/month) as a result of the newly established momentum resultling from new CRO, Investigator meeting, videos, etc. it would take only 6 months - or say May 2024 to get to 150.

12/month would be April 2024...and so on.

Exciting times ahead for Spectral shareholders !

MM


PS  Now would be a good time to introduce more US investors to Spectral, don't you think?


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