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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 SouthernTierTomon May 20, 2021 3:29pm
223 Views
Post# 33241897

Really feels like more a FDA thing than anything else

Really feels like more a FDA thing than anything elseIn August of 2014 ( the 22nd I believe ) the FDA declared Meddwell and Spectral as "NO LONGER available for purchase" buy those under the agency umbrella.  How much did they "already own"? we don't know.

In 2012 Altercyte was founded as a private entity that involves many key EDT players..both old and knew.  When asked during AGM proceeding eager EDT retail beavers were told that Altercyte was "for future use" and we were led to believe it was not anything we needed clarification on.

In 2016 our FDA phase 3 trial ws completed and deemed a "FAILURE" as per Natalie from Reuters, she was "granted" a special interview early the morning of October 3rd 2016 while our bid / ask was at 1 penny and our financing partners were preparing to announce 4 and 5 cent SP targets on CNBNN.  Our first real exposure / piece of marketing from our "partners" on Canada's business network.

Days after the phase 3 Euphrates finished, CTSO made claims around a Sorb XL filter being potentially superior to PMX as it removed endotoxin at similar rates and added cytokine absorbtion. Like a thong on a well nutrioned person, XL has been not seen in a meaningful way since.

In 2017 during the EDTXF AGM, a special member of the retail holder group brought the XL, Oxiris and PMX results to the attention of the "crowd", the paper authored by our current CMO was the main topic of the AGM Q&A and occupied much of the Q&A presentation,  The author, also acting as the lead DSMB person in our phase 3 Euphrates was referred to as our "friend"

days after our 80 -90% reduction in share price, our then CFO SOLD all 225K shares and Stockhouse specialists inboxed key listeners all about the sale.  days later the 225K shares were bought back in a corrective measure to cancel out the hasty act.  Once again key Stockhouse members cirulated the activity in a timely fashion.

In the Fall of 2017 a key current member of our management team publically questioned the cost to efficacy ratio of PMX after Dr. Anton Nelli made a very mesningful speech regarding the phase 3 Euphrates results and post-hoc ( aka "deep-data-dive" ) analysis of the phase 3 results.  He explained the 1/3 of severely septic patients being "void of bacterial infection", pointed to the 21% absolute efficacy and made comparisons to phase2 results and also the Euphas2 registry.

This is a very rude-imentary MD&A brought to you by the STIG and based on my failing memory, I challenge and welcome all corrective measures.

Are you supposed to by "worried" about this day's activity...my answer is YES...should you be woriied about today's activity...well...do your own DD is perhaps the most appropriate answer.

PLEASE do your own DD and never trust ....well anyone ; - (

Bon chance,
Tom
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