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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

Comment by mercedesmanon Aug 05, 2020 6:14pm
201 Views
Post# 31369583

RE:Bullet Two

RE:Bullet Two
AmorFatiforlife wrote: Anyone care to speculate when EDT may receive the second allotment from Baxter? Regards



Essentially there are at 10 patients now.  Need 150 to complete Tigris trial (assuming not early stop for efficacy, Covid urgency, etc. - still possibilitties)

So over the next 14 months (Sept 2020 to Dec 2021) 140 more patients are needed to get to 150 (Q4 2021).  = 10 per month.  (assumes FDA approves 5 more sites?) 

Interim Data at 1/2 way point. = 75.   (Including initial 9) this = 6.5 more months (say 7).  Counting from Sept 1 = March 2021.  

Baxter gets 30 (60?) days to review Interim data.   

Potentially cuts a checque (if they like what they see) May 2021.  (6 months later than what might have been the original plan.).  In time for May  2021 AGM, and allowing for another round of options?

MM



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