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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

Comment by oilandgasmanon Nov 30, 2021 1:08pm
130 Views
Post# 34180975

RE:Questions for the company.

RE:Questions for the company.
What's the status of finding a distribution partner for Sami and/or Dimi?
 
If vaccine mandates are driving staffing shortages at dialysis clinics, then why not conduct the Dimi trial in only red states that don't have mandates in place?
 
Is Davita going to be one or more of the Dimi trial sites?
 
What degree of confidence do you have that Dimi trial will indeed start in the first quarter?
 
Are you having any supply change issues over all, and especially concerning the chip shortages in regards to both of the pumps?
 
Does the Tigris trial have any rules in place for stopping the trial early due to efficacy?
 
In terms of patient enrollment into Tigris, how many patients would you consider to be a good month?
 
Has there been any discussion about restarting the push for PMX as a treatment for Covid symptoms?
 
Can you please explain what the EDEN observational study is and when do you see it starting?
 
Have there been any advancements in the EAA distribution deal in Europe?
 
How does our world wide rights to hemoperfusion work and do you ever see this as impactful to revenue?
 
Can the NxStage pump and the Outset pump perform hemoperfusion?
 
When will the PD dialysis application be submitted to the FDA?
 
When will the electronic/wifi monitoring software application for Dimi be submitted to the FDA?
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