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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

Post by mercedesmanon Nov 14, 2023 11:13am
248 Views
Post# 35734400

Potential Outcomes at 76 patients - wow !

Potential Outcomes at 76 patients - wow !Figure 4 in the latest paradigm report (reach out to IR if you haven't already received your copy)

Shows outcome at various current ARR (absolute risk reductions) to projected ARR assuming no additional PMX efficacy

For example if current ARR is at 30% the worst they could end up is 17.7% (with only 7.6 needed per the Kellum paper)


The way the Paradigm author puts it....


From this analysis, EDT only needs to show a 7% absolute risk reduction (ARR) for the 150-patient TIGRIS trial to have a 96% probability of showing an overall benefit of PMX over standard of care, assuming the results from the prior 179 patients from EUPHRATES are given a 75% weighting. If the current TIGRIS ARR is ~15%, which is reasonable given management’s continued statements that the results are exceeding expectations, PMX could have no additional benefit for the remaining 74 patients and the final ARR would be ~7.6%, above this 7% threshold

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I have no inside info...but I suspect that we are above 20% ARR currently in Tigris.  

I suspect the more patients they add to Tigris, the faster they get to a projected final of > 20%.  I suspect 20% might be a magic number that would result in a much higher ultimate market acceptance and possibly selling price for PMX.

JME&HO  DYODD.

MM
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