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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 Sep 07, 2023 10:00am
191 Views
Post# 35623843

RE:RE:Six, eighteen, four

RE:RE:Six, eighteen, four

...2 months ago the # sites increased by 20% ? ( 3/15 sites)

Will the potential enrollment rate have increased again (3 more) by the end of this month? 

Fewer FUD dummies are now predicting it will take 2, 3, 4+ years to get to 90 and 7 years to achieve 150? 

They are now down to 2 years on the 150.  That in itself is a major negative stretch - given: (1) more sites, (2) better sites - ie. newer ones enrolling at a faster pace, and (3) the shot in the momentum increase from the May meeting, etc.)

Now add in the TV spot.

The FUD workers are down to extrapolating the month of August's enrolment (the slowest month typically becasue of ICU staff vacationing)

Possible Pathway to 90 BEFORE YEAR END from an earlier prediction by MM: 

july +3. cumm. 68     happened
aug +4. cumm 72      happened
sept +5 cumm 77       TBD
oct +5  cumm. 82        TBD
nov + 6 cumm 88         TBD

I'm looing forward to a possible increase in the pace starting in Sept (post vacation period, new sites, etc.)

Personally, at 90, I am hoping for the release of some raw mortality stats at that time (interim data release) that might enable investors ( but at the very least Baxter) to statistically gauge the odds of ultimate FDA approval in this OPEN LABEL, BAYESIAN, CONFIRMATORY, 3B RCT TRIAL with a 28 DAY MORTALITY PRIMARY END POINT, clearing the pathway to a minimum of a $2BILLION USD market ( more likely $3-$5 B IMO) 

MM 

PS I will, of course, be accused of being a shill, but numbers and stats and trends don't lie... unlike FUD workers 
 

 

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