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Multiple Choice:

a) DaVita
b) CVS
c) Fresenius
d) all of above
e) none of the above.
 

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Multiple Choice:

a) DaVita
b) CVS
c) Fresenius
d) all of above
e) none of the above.
I'll take CVS for 500.00 .

The CVS earnings call was interesting ...Not a mention of "DEKA" or "Dialysis" despite the touted CVS market initiative .
And the DEKA site has no info on the CVS pump just a photo place holder where a description and run down were previously. Reminder for those playing along this is the same "Deka" pump Baxter threw money at before backing away from the company and pump rehash.

Seems CVS is or will be pump shopping soon enough or at least the way I read it.

CVS transcripts

Deka site....Nice soft drink machine..lol
 

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This was as close as anyone came to speaking of renal care during the call....very strange.

"Our 2021 performance demonstrates our ability to anticipate, deliver, and exceed consumers' expectations for health care. Consumers are a major force driving change in health care and we continue to engage successfully with individuals in more places and on their terms, virtually in the home and in their local community. Customers and clients continue to realize the superior value we are providing with our integrated health solutions, particularly those that address the most prevalent, costly and complex health conditions, such as diabetes, cancer and chronic kidney disease."
 

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I'll take CVS for 500.00 .

The CVS earnings call was interesting ...Not a mention of "DEKA" or "Dialysis" despite the touted CVS market initiative .
And the DEKA site has no info on the CVS pump just a photo place holder where a description and run down were previously. Reminder for those playing along this is the same "Deka" pump Baxter threw money at before backing away from the company and pump rehash.

Seems CVS is or will be pump shopping soon enough or at least the way I read it.

CVS transcripts

Deka site....Nice soft drink machine..lol
Yep. Deka should stick to bionic arms and soda machines.

CVS earnings are impressive. Throwing off lots of cash and they certainly would have a leverageable database. I'm just not sure that DaVita doesn't need a new pump more (vs using a competitor pump). HD is happening, and they need to protect their main source of revenue...or risk becoming the next Blockbuster Video. CVS will survive without Dialysis. Best case? A bidding war.
 

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Database..Meaning CVS being" Aetna" as well? 39 million Americans under that umbrella( Database) makes CVS a sized monster player.
Bidding war...seems a ways off , my hope is someone see's the value in beating competitors to the FDA approval punch on the pump.
 

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Database..Meaning CVS being" Aetna" as well? 39 million Americans under that umbrella( Database) makes CVS a sized monster player.
Bidding war...seems a ways off , my hope is someone see's the value in beating competitors to the FDA approval punch on the pump.
Supposedly formal FDA (home use) is 2023. I suspect that an interested party will make a move before then, if favorable/early feedback in the 35 person Trial. Hopefully a big player takes at least a piece of a spun-off company (Dialco), and gets a ROFR of sorts.
In the meantime, there was news today that the Tigris Trial (PMX) is picking up pace, with results continuing to "exceed expectations". I don't see it going the full 150 before FDA makes a decision...possible this part is fully cooked and ready to serve, before end of 2022 as well.
 

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Yep good news.
I'd love to agree with you but the FDA has never given Spectral a break..Unfortunately this will go the full 150 I think..what I worry about is the time anything is taking involving the FDA once paper work enters the building....See ADVL.



fed0372a-a1bf-4e28-ad49-8534c1204b3c.jpg
SPECTRAL MEDICAL REPORTS PROGRESS ON TIGRIS CLINICAL TRIAL

Patient mortality data continues to exceed expectations

Recent FDA approved SOFA amendment contributing to increased patient enrollment


TORONTO, Canada – February 11, 2022 – Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late stage theranostic company advancing therapeutic options for sepsis and septic shock, as well as commercializing a new proprietary platform targeting the renal replacement therapy market through its wholly-owned subsidiary Dialco Medical Inc. (Dialco), today provided a clinical trial update on Tigris, a follow on study designed to build on knowledge gained from the earlier EUPHRATES trial, evaluating the use of Polymyxin B Hemoperfusion (“PMX”) in a randomized controlled trial of adults treated for endotoxemia and septic shock. The Tigris trial end point is a reduction in the 28-day mortality in subjects with septic shock using the PMX hemoperfusion cartridge versus standard of care.

Key Tigris Trial Updates:
  • Patient mortality data continues to exceed expectations
  • 30 patients randomized to-date (out of the 150 total patients to be enrolled in the Tigris trial)
  • Of the three patients enrolled over the past month, two were enrolled as a result of the recent FDA approved protocol amendment allowing for the use of sequential organ failure assessment (SOFA) scoring as inclusion criteria into the study
  • Investigator meeting scheduled for February 17, 2022, expected to be well attended by existing and new trial sites

Chris Seto, CEO of Spectral, commented, “We are highly encouraged by both the patient mortality data thus far, as well as the recent rate of patient screening, enrollment, and randomization activity. We attribute the increased enrollment to a number of factors, including the implementation of our United States Federal Food and Drug Agency (FDA) approved SOFA amendment and new sites coming online. Notably, we recently opened enrollment at UC Health Memorial Hospital in Colorado Springs, one of the highest enrolling sites in the Euphrates trial, which has already enrolled two patients in the past month alone. We look forward to our upcoming investigator meeting later this month, which we expect will be well attended and will feature Professor Claudio Ronco, MD, and Dr. Paul Walker as keynote speakers.”

“It’s gratifying to see the commitment from our participating Tigris sites,” said Dr. John Kellum, Chief Medical Officer of Spectral. “COVID-19 has again disrupted research activities across the U.S., but the passion for sepsis care and research shown by our sites is quite remarkable. We have still managed to enroll patients even with COVID cases occupying most of the ICU beds. Now that COVID cases are falling, we expect a meaningful increase in enrollment in the coming weeks. Equally important, early efficacy signals continue to exceed targets.”

About Spectral
Spectral is a Phase 3 company seeking U.S. FDA approval for its unique product for the treatment of patients with septic shock, Toraymyxin™ (“PMX”). PMX is a therapeutic hemoperfusion device that removes endotoxin, which can cause sepsis, from the bloodstream and is guided by the Company’s Endotoxin Activity Assay (EAA™), the only FDA cleared diagnostic for the risk of developing sepsis.

PMX is approved for therapeutic use in Japan and Europe, and has been used safely and effectively on more than 300,000 patients to date. In March 2009, Spectral obtained the exclusive development and commercial rights in the U.S. for PMX, and in November 2010, signed an exclusive distribution agreement for this product in Canada. Approximately 330,000 patients are diagnosed with severe sepsis and septic shock in North America each year.

Spectral, through its wholly owned subsidiary, Dialco Medical Inc., is also commercializing a new set of proprietary platforms addressing renal replacement therapy (RRT) across the dialysis spectrum. SAMI is targeting the acute RRT market, while DIMI is targeting the chronic RRT market. Dialco is currently pursuing regulatory approval for U.S. in-home use of DIMI, which is based on the same RRT platform as SAMI, but will be intended for home hemodialysis use. DIMI recently received its FDA 510k clearance for use in hospital and clinical settings, and obtained its Health Canada license for use within Canadian hospitals, clinics and in home.

Spectral is listed on the Toronto Stock Exchange under the symbol EDT. For more information, please visit www.spectraldx.com.

Forward-looking statement
Information in this news release that is not current or historical factual information may constitute forward-looking information within the meaning of securities laws. Implicit in this information, particularly in respect of the future outlook of Spectral and anticipated events or results, are assumptions based on beliefs of Spectral's senior management as well as information currently available to it. While these assumptions were considered reasonable by Spectral at the time of preparation, they may prove to be incorrect. Readers are cautioned that actual results are subject to a number of risks and uncertainties, including the availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical studies, the ability of Spectral to take advantage of business opportunities in the biomedical industry, the granting of necessary approvals by regulatory authorities as well as general economic, market and business conditions, and could differ materially from what is currently expected.

The TSX has not reviewed and does not accept responsibility for the adequacy or accuracy of this statement.

For further information, please contact:
Mr. Chris Seto
CEO
Spectral Medical Inc.
416-626-3233 ext. 2004
cseto@spectraldx.com
Mr. Ali Mahdavi
Capital Markets & Investor Relations
416-962-3300
am@spinnakercmi.com

David Waldman/Natalya Rudman
US Investor Relations
Crescendo Communications, LLC
212-671-1020
edt@crescendo-ir.com
 

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I hear you on the FDA/Spectral history...but...they now have a couple of world renowned Dr's involved. (Kellum as CMO on leave form UofP, and Claudio Ronco out of Italy - probably the top Sepsis/dialysis Doc in the world who has been pushing HP for decades). Secondly, the only treatment for Sepsis currently is antibiotics. Kills over 300k Americans every year, and it's on the increase. If the mortality benefit is high enough, I think they find a way...or perhaps Baxter makes a pre-final-FDA approval offer with the benefit of an advanced preview of Tigris Interim Data. I'm sure they are following along very closely now on this Open Label Trial. Either way we are only talking a difference of maybe 9-12 months, and markets will begin to anticipate ultimate approval whether 2022 or 2023.
 

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I hear you on the FDA/Spectral history...but...they now have a couple of world renowned Dr's involved. (Kellum as CMO on leave form UofP, and Claudio Ronco out of Italy - probably the top Sepsis/dialysis Doc in the world who has been pushing HP for decades). Secondly, the only treatment for Sepsis currently is antibiotics. Kills over 300k Americans every year, and it's on the increase. If the mortality benefit is high enough, I think they find a way...or perhaps Baxter makes a pre-final-FDA approval offer with the benefit of an advanced preview of Tigris Interim Data. I'm sure they are following along very closely now on this Open Label Trial. Either way we are only talking a difference of maybe 9-12 months, and markets will begin to anticipate ultimate approval whether 2022 or 2023.
That would be different and amazing....Believe me I'm ready whenever the market picks up on the story
I'm holding a ton something around 550k and I may buy a little for my IRA coming up here.

good luck to you Beeker and anyone else who's gotten involved.. bozzie out till the next news
 

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That would be different and amazing....Believe me I'm ready whenever the market picks up on the story
I'm holding a ton something around 550k and I may buy a little for my IRA coming up here.

good luck to you Beeker and anyone else who's gotten involved.. bozzie out till the next news
I have a couple more than you. Better early than late. Good luck to you as well.
 

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Database..Meaning CVS being" Aetna" as well? 39 million Americans under that umbrella( Database) makes CVS a sized monster player.
Bidding war...seems a ways off , my hope is someone see's the value in beating competitors to the FDA approval punch on the pump.
Anthem with CVS * 39 million strong ... *Aetna is a nursing association..my bad.
Imagine owning the lowe$t co$t pump on the market that can do both peritoneal (Slow) and regular dialysis and having the power to influence or even direct witch machine you'd take home with you....Sadly you could use the Spectral pump from the on set of kidney disease to transplant or death.

39 million, the stats become mind blowing.$$$$$


States​

Fast Facts on Kidney Disease​


Chronic kidney disease (CKD) affects more than 1 in 7 U.S. adults—an estimated 37 million Americans.1 For Americans with diabetes or high blood pressure—the two most common causes of kidney disease—the risk for CKD is even greater. Nearly 1 in 3 people with diabetes and 1 in 5 people with high blood pressure have kidney disease.1 Other risk factors for developing kidney disease include heart disease and a family history of kidney failure.
Despite the prevalence of kidney disease in the United States, as many as 9 in 10 people who have CKD are not aware they have the disease.1 Early-stage kidney disease usually has no symptoms, and many people don’t know they have CKD until it is very advanced. Kidney disease often gets worse over time and may lead to kidney failure and other health problems, such as stroke or heart attack. Approximately 2 in 1,000 Americans are living with end-stage kidney disease (ESKD)—kidney failure that is treated with a kidney transplant or dialysis.2
Learn more about kidney disease from the National Institute on Diabetes and Digestive and Kidney Diseases (NIDDK). The NIDDK spearheads research to improve kidney disease management and treatment. For information about current studies, visit ClinicalTrials.gov NIH external link.

Key Kidney Disease Statistics​


Chronic kidney disease (CKD)​

According to the Centers for Disease Control and Prevention’s (CDC) Chronic Kidney Disease in the United States, 2021 External link report
  • CKD is slightly more common in women (14%) than men (12%).
  • CKD is more common in non-Hispanic Black adults (16%) than non-Hispanic white adults (13%) or non-Hispanic Asian adults (13%).
  • About 14% of Hispanic adults have CKD.
  • CKD is most common among people ages 65 or older (38%), followed by people ages 45 to 64 (12%) and people ages 18 to 44 (6%).
End-stage kidney disease (ESKD)
According to the United States Renal Data System 2020 Annual Data Report External link
  • Nearly 786,000 people in the United States are living with ESKD, also known as end-stage renal disease (ESRD), with 71% on dialysis and 29% with a kidney transplant.
  • For every 2 women who develop ESKD, 3 men develop ESKD.
  • For every white person who develops ESKD, 3 Black people develop ESKD.
  • For every 3 non-Hispanic people who develop ESKD, 4 Hispanic people develop ESKD.
  • At the end of 2018, 12.5% of all patients undergoing dialysis performed dialysis at home. The number of patients performing home dialysis more than doubled between 2008 and 2018.
  • Among patients with ESKD who were initially waitlisted in 2013, median wait time for a kidney transplant was 49.2 months.
    • Median wait time is longer for adults (46.0 months to 59.1 months, depending on age bracket) than for children 17 years or younger (7.3 months).
    • Median wait time is longer for Black patients (59.9 months) than for white patients (41.3 months).
    • Median wait time is longer for Hispanic or Latino patients (55.8 months) than for non-Hispanic patients (47.4 months).
Based on U.S. Organ Procurement and Transplantation Network External link data
  • In 2020, a total of 22,817 kidney transplants were completed in the United States.
  • As of August 2021, 90,201 people were on the waiting list for a kidney transplant.
Medicare spending
According to the United States Renal Data System 2020 Annual Data Report

Mortality​

According to the United States Renal Data System 2020 Annual Data Report External link
  • In 2018, adjusted mortality was more than twice as high among Medicare beneficiaries ages 66 years or older with CKD (96.0 per 1,000) compared with those without CKD (41.0 per 1,000).
  • Adjusted mortality decreased by nearly 15% in patients receiving hemodialysis and by nearly 20% in patients receiving peritoneal dialysis between 2009 and 2018.
  • Adjusted mortality is significantly lower in patients with a kidney transplant (48.9 per 1,000) compared with patients receiving dialysis (160.8 per 1,000).

References​

[1] Centers for Disease Control and Prevention. Chronic Kidney Disease in the United States, 2021. Centers for Disease Control and Prevention, US Department of Health and Human Services; 2021.
[2] United States Renal Data System. 2020 USRDS Annual Data Report: Epidemiology of Kidney Disease in the United States. National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, US Department of Health and Human Services; 2020.
Last Reviewed September 2021
 

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Intrigued by this play. Throwing some money in...

It's all about diagnostics from here. They have diagnostics and a remedy against some nasty stuff.
Hi Beeker, something doesn't seem right. You just disclosed that you own somewhere around 750k shares, an amount that rivals Spectral executives. But in this post, you seem to imply that you are a newcomer to the stock and kicking the tires. I doubt 750k shares even sold from early Dec to now so it is clear that you were a major shareholder well before you first posted here. You seem very knowledgeable about the stock for a newcomer too. Are you playing a game?
 

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Pezdala. Thank you for your interest in my holdings. Allow me to rectify some of the errors in your post.
1. Many millions of shares have changed hands since early Dec (not even including under-reported shares that trade on other exchanges)
2. I have been a quiet shareholder for a few years, and recently decided to add quite a bit more as their two remaining key FDA approvals get closer to reality.
3. I do not own 750,000. I have no idea where you came up with that number.
The tone of your post seems quite belligerent. Is this not a public forum where anyone is entitled to post?
 

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Timelines..At 90 participants ( the dotted line) Baxter can exercise the option for exclusivity on PMX.
Baxter will have the data to pass or play.

View attachment 20781
It'll be interesting to get an update from the Company as to which line we are tracking - which has a worst Case of 90 enrollees by October 2022 (the dotted line above). 90 triggers the Interim Data Review, the point at which Baxter must make a decision if they will put in millions more to help fund the remainder of the Tigris Trial. With reportedly results that, so far, are "exceeding expectations", it stands to reason that they would want to preserve their place as the eventual (exclusive?) distributor of PMX in North America.
 

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It'll be interesting to get an update from the Company as to which line we are tracking - which has a worst Case of 90 enrollees by October 2022 (the dotted line above). 90 triggers the Interim Data Review, the point at which Baxter must make a decision if they will put in millions more to help fund the remainder of the Tigris Trial. With reportedly results that, so far, are "exceeding expectations", it stands to reason that they would want to preserve their place as the eventual (exclusive?) distributor of PMX in North America.
If the carrot and stick can't get you one participant per site every month then you'll need a bigger carrot or stick.

Starting on March 1st saying every site gets on person to participate.
15 participants x 8 months = 120 plus the 15 they already have ? 135.
Seems conservative if you're "sticking" people hard enough. This won't be stopped early the FDA giving the inclusion in scoring was giant, The 150 is nothing despite the ridiculously drawn out timelines. The FDA timeline after the conclusion is my next thought.
 

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If the carrot and stick can't get you one participant per site every month then you'll need a bigger carrot or stick.

Starting on March 1st saying every site gets on person to participate.
15 participants x 8 months = 120 plus the 15 they already have ? 135.
Seems conservative if you're "sticking" people hard enough. This won't be stopped early the FDA giving the inclusion in scoring was giant, The 150 is nothing despite the ridiculously drawn out timelines. The FDA timeline after the conclusion is my next thought.
A few thoughts:
  • They already have 30 enrollees (as per NR Feb 11)
  • Not sure bout "sticks". Investigator Meeting on Feb 17, could have provided a nice carrot. Kellum (UoP) led the festivities. He is well thought of in the world of Sepsis/dialysis...as is the keynote speaker Claudio Ronco out of Italy.
  • I would be pleased with an average of 10 per month (=90 by July or August)
 

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A few thoughts:
  • They already have 30 enrollees (as per NR Feb 11)
  • Not sure bout "sticks". Investigator Meeting on Feb 17, could have provided a nice carrot. Kellum (UoP) led the festivities. He is well thought of in the world of Sepsis/dialysis...as is the keynote speaker Claudio Ronco out of Italy.
  • I would be pleased with an average of 10 per month (=90 by July or August)
At one point the company talked about using a" Carrot and Stick" method for moving the trial along quickly.
Money incentives for enrolling I'd guess
 

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At one point the company talked about using a" Carrot and Stick" method for moving the trial along quickly.
Money incentives for enrolling I'd guess
Perhaps. By way of "sticks", any given hospital gains a certain amount of "prestige" when it participates in medical research (grants or access to future grants?). A failure to bring forth a sufficient number of patient candidates, could result in the site being dropped. It would not surprise me if that was something that may have been thrown out there during the Investigator Meeting.
 

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Perhaps. By way of "sticks", any given hospital gains a certain amount of "prestige" when it participates in medical research (grants or access to future grants?). A failure to bring forth a sufficient number of patient candidates, could result in the site being dropped. It would not surprise me if that was something that may have been thrown out there during the Investigator Meeting.
Way before last weeks meeting, I hear it went well BTW.
I'll look for the quote it was either Seto, Kellum or Walker who mentioned it.
 

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