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

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Post by txbioinvon Jul 31, 2013 1:02am

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Post# 21640610

EARLY FDA APPROVAL?

SDI BB Regulars,

The FDA may deem this good to go after the 2nd interim look? Its already approved in Japan and EU; if the next peek looks good they may say your good to go based on a conditional completion of the phase 3 trail, etc.

Also, insider buys lately are interesting............................

What says the regulars here? I'm dipping my toes here before eob friday.

GL longs

ps- sqr is the one who put the word out, only took me 2 yrs to get the DD done.

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