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Bullboard - Stock Discussion Forum Spectral Medical Inc T.EDT

Alternate Symbol(s):  EDTXF

Spectral develops devices for unmet medical needs. Sepsis occurs in 1.7M Americans/year causing 250K deaths, often caused by endotoxin. Our devices measure and remove endotoxin from the bloodstream. An FDA confirmatory trial is underway. Dialco, a Spectral sub, offers SAMI, a novel instrument for renal replacement, cleared by FDA. Dialco is seeking FDA approval for DIMI a unique home dialysis... see more

TSX:EDT - Post Discussion

Spectral Medical Inc > AGM Disclosures
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Post by Accountprince on Jun 21, 2022 10:43am

AGM Disclosures

Hope some of the posters here took the time to listen to the AGM presentation.  Some gems in the presentation that is available in SEDAR - I encourage each of you to get it and read it:

EAA and PMX - Baxter and Spectral working closely on pre-launch activities suggests Baxter much more enthused now.  Kellum did add verbally to "exceeding expectations" that results are "greatly" - so putting it together you'd have "greatly exceeding expectations".  The presentation also disclosed that they have submitted to the FDA for a "breakthrough designation".  I am drawing a conclusion and path - how about the rest of you?

Dialco - the presentation talks about developing a "strategic partnership" to bring in funds directly.  Kellum said progressing but discussions preclude disclosure of details at this time.  That implies the discussions are more advanced that the "developing" stage.  Sam Amory very impressive speaking and with what he's achieved in a very short period of time.  Looks like Dialco has the goods and people to get there.  Seto repeated his "when not if" for DIMI in terms of FDA approval.

This one didn't leave me feeling same old...same old...just the opposite
Comment by mercedesman on Jun 21, 2022 10:56am
Correct AP And lets not forget that they are making endotoxins sexy again!  Not that they ever were not a turn on for me. Working with FDA to increase # of sites to 25 – increase enrollment Sepsis cases increasing – enrollment increasing SOFA score protocol amendment – last 4 of 7 patients enrolled MM
Comment by mercedesman on Jun 21, 2022 11:03am
Re: Baxter Beyond "breakthrough" designtaion (submitted), as you pointed out,  you also have, apparently: Baxter working on a branding/pre-launch marketing strategy - suggesting that they see the probability of ultimate approval as being very high. And of course the PriMax Trial -is VERY interesting.  Imagine being able to hit the ground running, with an established network ...more  
Comment by mercedesman on Jun 21, 2022 11:14am
Re: DIMI Usability Trial Under the heading of "confirmed" : University of Michigan "confirmed"   (4 patients) Partner # 2  ("confirmed" ?!?!?!?!?)   (6 sites, 20-30 patients) Two more Clinics/sites apparently in the works. How long will # 2 be kept a secret?  I'm excited to know the answer ! MM
Comment by Accountprince on Jun 21, 2022 11:28am
Yep.  Partner #2 would effectively get them close or there for a total of 35 patients.  And if this partner is selected for "strategic" reasons they would participate in or control the trial.  Perhaps this partner would provide the funding? And since the Partner #2 is "confirmed" but not identified does this dovetail to Kellum's comment that he can't ...more  
Comment by mercedesman on Jun 21, 2022 11:53am
If # 2 is a big name and they participate (directly or indirectly) in the funding,  I wouldn't want to be "out" of the stock when the news came out. I may even have to buy back some of the trading postion I sold on the recent "speculative" run-up. Anyone got Level II access? MM
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