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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

Bullboard Posts
Post by schemehatcheron May 21, 2014 9:20am
263 Views
Post# 22581537

Russian study example of exclusion request ?

Russian study example of exclusion request ?
The request for the trial exclusion was submitted to the FDA on May 1 2014.  As previously stated by Square, it appears as though the sicker the patient, the greater the efficacy gap between PMX ( Toraymyxin ) treated patients and SOC ( standard of care patients )  This clearly on display in Russian study where 65% of the SOC died, and 42% of the PMX group died.  Remeber the PMX group was 50% larger ( 65 vs. 40 patients )

With the slowing pace of recruitment, the exclusion would appear to be a significant event for the company as they slow the pace of recruitment prior to changing the trial parameters.  The US analyst is quite smart, as he indicated soon after the interim sentence or two released by the company that a removal of the "less sick" may be in order.  He also pointed to the exclusion as an evrent to bring investor's eyes back to the story.

My opinion on the current price and trading would be that a lack of volume and inbterest favours the few controlling hands that manage the trading.  Any uptick in volume or interest from these levels has NO benefit to the few that hold LARGE quantities of the stock.  A spike in the supply / demand equation would cause the controlling interests to cough up some of their position to meet demand. IMHO

Enjoy the day,
Scmhatcher
Bullboard Posts