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Spectral Medical Inc T.EDT

Alternate Symbol(s):  EDTXF

Spectral develops devices for unmet medical needs. Sepsis occurs in 1.7M Americans/year causing 250K deaths, often caused by endotoxin. Our devices measure and remove endotoxin from the bloodstream. An FDA confirmatory trial is underway. Dialco, a Spectral sub, offers SAMI, a novel instrument for renal replacement, cleared by FDA. Dialco is seeking FDA approval for DIMI a unique home dialysis enabler. These devices have large commercial potential


TSX:EDT - Post by User

Post by mercedesmanon May 24, 2023 11:07am
198 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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