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

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Spectral Medical Inc > Paradigm needs to update…

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Post by mercedesmanon Jul 24, 2022 12:35pm

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Post# 34846333

Paradigm needs to update…

Given all the good things happening

Example:

increasing rate of enrollment
ARC validation
Sam Amory
DIMI participant # 2
etc.

they were at 75% odds of PMX approval ( Feeling a need to show some conservatism I guess)

But given " greatly exceeding Expectations " in the Tigris "confirmatory trial"

I think they should show more confidence with even higher odds of approval