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.

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Spectral Medical Inc > Could CG have a peek at raw data?

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Comment by mercedesmanon Nov 08, 2024 9:23am

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Post# 36302903

RE:RE:RE:RE:RE:Could CG have a peek at raw data?

Then there is always the possibility of some creative solutions such as:

An offer to purchase with a 4-6 month time frame with a material break-up fee .., or an offer for $X with a premium of $Y upon successful Top Line result ...and or an additional premium of $Z if MB exceeds 15% , etc.

Or the Bayesian analysis paper put out by Kellum and others may be sufficient to allow CG to conclude ( as Paradigm did) that the bar to approval is actually lower than 10% and that after 135 patients, it's virtually guaranteed statistically.

MM

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