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 > how long is in FDA "FAST TRACK" APPROVAL

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Comment by RickyBobbyTOon Jul 12, 2022 12:28pm

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RE:RE:how long is in FDA "FAST TRACK" APPROVAL

The company has an official statement that they think the trial completion will be somewhere in the summer of 2023. Leave some room for error. You can also plug your own data by looking at historical enrolment rate and trying to project going forward.

goldyhawk wrote: EDT's breakthrough designation probably means quicker FDA attention and/or approval
Anyone know what time period that might require ?

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