ESS
Essex Property Trust, Inc
stock NYSE

FYI I have a large position in this puppy.
Expect it to at least triple when it gets FDA approval from takeout offer. Just got FDA acceptance for filing of their PMA application. Spectral Medical Inc. focuses on the development and commercialization of products for the treatment of septic shock in the United States, Italy, Ireland, Russia, and internationally. Their Chief Medical Officer is [John Kellum](https://www.linkedin.com/in/john-kellum-306b692b1/) a world renown leader in critical care medicine with pioneering contributions to sepsis research, acute kidney injury, biomarkers, and precision-guided approaches to patient care.
# Spectral Medical Announces U.S. FDA Filing of PMA Application for PMX
[T.EDT](https://stockhouse.com/companies/quote?symbol=t.edt) | June 25, 2026
TORONTO, June 25, 2026 (GLOBE NEWSWIRE) -- **Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT),** a late-stage theranostic company advancing therapeutic options for sepsis and septic shock, today announced that the U.S. Food and Drug Administration (“FDA”) has completed its filing review and formally filed the Company's Premarket Approval (“PMA”) application for PMX, the Company’s endotoxin removal therapy for patients with endotoxic septic shock (“ESS”).
FDA acceptance for filing of the PMA application follows completion of the Agency's filing review process and confirms that the application contains all the information needed to proceed with the substantive review. The PMA application includes clinical, non-clinical, manufacturing and quality system information supporting the use of PMX in adult patients with ESS identified using Spectral’s FDA-cleared Endotoxin Activity Assay (“EAA™”).
“The FDA’s filing of our PMA application represents a defining milestone for Spectral and reflects years of focused clinical, regulatory and operational execution,” said Chris Seto, Chief Executive Officer of Spectral. “We believe the totality of evidence supporting PMX demonstrates the potential for a targeted therapy approach in endotoxic septic shock, an area of critical unmet medical need with limited therapeutic innovation over the past several decades. We have worked closely with the FDA throughout the PMA process and have been deliberate in assembling what we believe is a complete and compliant application. We look forward to continuing our engagement with the Agency during the review process.”
John A. Kellum, Chief Medical Officer of Spectral, added, “Endotoxic septic shock remains one of the most challenging conditions encountered in critical care medicine, with persistently high mortality despite advances in supportive care. The Tigris trial further strengthens the clinical evidence supporting PMX and the importance of identifying patients with elevated endotoxin activity using EAA™. We are grateful to the investigators, research coordinators and patients who participated in the clinical development of PMX and helped advance this important work. We are encouraged to have reached this important stage of the regulatory process.”
As previously announced, the Tigris trial met its pre-specified primary endpoint, demonstrating a 95.3% probability of benefit for 28-day all-cause mortality in the adjusted analysis, as well as a greater than 99% probability of benefit at 90 days. Complete results of Tigris trial out to 90 days were published in March of this year in the journal *The Lancet Respiratory Medicine.* The full Bayesian analysis of Tigris revealed an absolute risk reduction for mortality of 10.3% at 28 days corresponding to a number needed to treat (NNT) to prevent one death of 9.7 and 15.5% at 90-days corresponding to a NNT of 6.5. Long-term follow-up demonstrated that the survival benefit observed at 90 days persisted through 12 months, with mortality rates of 52.8% in PMX-treated patients compared to 66.7% in the standard-of-care group, representing an absolute risk reduction of 13.9%.
The FDA's filing of the PMA application initiates the substantive review phase of the PMA process. Spectral will continue to work closely with the Agency throughout the review and will provide updates as appropriate.
**About the Tigris Trial**
Tigris was a confirmatory Phase 3 study evaluating PMX in addition to standard care versus standard care alone in adult patients with endotoxic septic shock and elevated endotoxin activity levels measured using EAA™. The trial was designed as a 2:1 randomized study of 150 patients utilizing a Bayesian statistical framework.
As previously reported, the adjusted analyses demonstrated:
* 95.3% probability of benefit for 28-day all-cause mortality;
* Greater than 99% probability of benefit for 90-day mortality; and
* A favorable safety profile consistent with prior PMX studies and clinical experience.
\-----------------------------------------Some posts from Stockhouse board--------------------
My total guess is we get an FDA Decision by November 27, 2026.  There are NO Safety issues with PMX, Zero as far as I know and PMX has been in use for over 20 years.  SPECTRAL having been before the FDA so many times, the staff there are very familiar with the product.  IMO I don't see how the FDA does Not Approve this. 
I mean Eli Lilly's Drug XIGRIS which was approved by the FDA, has major Safety issues such as major bleeding, gastrointestinal issues and Brain Hemorrhages, amongst other things.  Yet the FDA approved the Drug and it was only removed from the Market in 2011, when Eli Lilly admitted subsequent clinical trials showed NO Survival Benefit.  Whereas today, it looks like SPECTRAL has shown a 17% survival benefit.  So my question is, if XIGRIS got approved, with all its problems and Zero Benefit, how can SPECTRAL not be approved ?  Therein lies the question.  I would have thought VANTIVE would have bought Spectral by now.  Oh well, I hope it gets approved.  This is OPINION NOT ADVICE and good luck everyone.
\----------------------------------------------------------------------------------------------------------
I'd take a smidge less than 2Billion for a buyout today, versus a full 2Billion valuation upon FDA approval.  I think the ball is mostly in Vantive's court on that matter.  Vantive has by far the most to gain by hooking up with Spectral because it's pure symbiosis to combine PMX/EAA with Vantive's Prismax. 
Spectral owns the only high margin razor blade and Vantive owns the low margin "handle" that PMX fits onto.  And Vantive will also gain exclusive profits to all of the necessary accouterments such as disposable tubing, fitings, clamps, service contracts, etc., which have a pretty decent margin. Plus it will allow Vantive to increase their 50% market dominance of Prismax towards 60% and beyond, because once PMX becomes part of the SOC, no hospital in America will upgrade their CRRT machines to a machine that can't accomodate this new treatment paradigm that will save little Jimmy's beloved grandpa.    
In my opinion, Carlyle Group will never be able to IPO their low margin dinosaur without Spectral in their stable.  Again, in my opinion as of today, Spectral would only entertain a buyout offer of $4 usd, and upon FDA approval, that number will rise to $5 usd or higher, depending on how quickly all USA hospitals will adopt the new SOC that is clearly coming. 
I could actually see hospitals today, that don't have a Prismax CRRT machine, taking into acount that this new treatment shift is about to become part of the SOC, and they need to be ready for it.  Any hospital in the current yearly sales cycle for a new CRRT machine upgrade, especially the one's that currently use a Braun, Fressenius, Takeda, or Nikkiso CRRT machine, in other words "the other 50%," will definitely have this in their mind, and if they don't, I'm certain the Vantive sales reps will remind them of it in their bid proposals. 

FYI I have a large position in this puppy.
Expect it to at least triple when it gets FDA approval from takeout offer. Just got FDA acceptance for filing of their PMA application. Spectral Medical Inc. focuses on the development and commercialization of products for the treatment of septic shock in the United States, Italy, Ireland, Russia, and internationally. Their Chief Medical Officer is [John Kellum](https://www.linkedin.com/in/john-kellum-306b692b1/) a world renown leader in critical care medicine with pioneering contributions to sepsis research, acute kidney injury, biomarkers, and precision-guided approaches to patient care.
# Spectral Medical Announces U.S. FDA Filing of PMA Application for PMX
[T.EDT](https://stockhouse.com/companies/quote?symbol=t.edt) | June 25, 2026
TORONTO, June 25, 2026 (GLOBE NEWSWIRE) -- **Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT),** a late-stage theranostic company advancing therapeutic options for sepsis and septic shock, today announced that the U.S. Food and Drug Administration (“FDA”) has completed its filing review and formally filed the Company's Premarket Approval (“PMA”) application for PMX, the Company’s endotoxin removal therapy for patients with endotoxic septic shock (“ESS”).
FDA acceptance for filing of the PMA application follows completion of the Agency's filing review process and confirms that the application contains all the information needed to proceed with the substantive review. The PMA application includes clinical, non-clinical, manufacturing and quality system information supporting the use of PMX in adult patients with ESS identified using Spectral’s FDA-cleared Endotoxin Activity Assay (“EAA™”).
“The FDA’s filing of our PMA application represents a defining milestone for Spectral and reflects years of focused clinical, regulatory and operational execution,” said Chris Seto, Chief Executive Officer of Spectral. “We believe the totality of evidence supporting PMX demonstrates the potential for a targeted therapy approach in endotoxic septic shock, an area of critical unmet medical need with limited therapeutic innovation over the past several decades. We have worked closely with the FDA throughout the PMA process and have been deliberate in assembling what we believe is a complete and compliant application. We look forward to continuing our engagement with the Agency during the review process.”
John A. Kellum, Chief Medical Officer of Spectral, added, “Endotoxic septic shock remains one of the most challenging conditions encountered in critical care medicine, with persistently high mortality despite advances in supportive care. The Tigris trial further strengthens the clinical evidence supporting PMX and the importance of identifying patients with elevated endotoxin activity using EAA™. We are grateful to the investigators, research coordinators and patients who participated in the clinical development of PMX and helped advance this important work. We are encouraged to have reached this important stage of the regulatory process.”
As previously announced, the Tigris trial met its pre-specified primary endpoint, demonstrating a 95.3% probability of benefit for 28-day all-cause mortality in the adjusted analysis, as well as a greater than 99% probability of benefit at 90 days. Complete results of Tigris trial out to 90 days were published in March of this year in the journal *The Lancet Respiratory Medicine.* The full Bayesian analysis of Tigris revealed an absolute risk reduction for mortality of 10.3% at 28 days corresponding to a number needed to treat (NNT) to prevent one death of 9.7 and 15.5% at 90-days corresponding to a NNT of 6.5. Long-term follow-up demonstrated that the survival benefit observed at 90 days persisted through 12 months, with mortality rates of 52.8% in PMX-treated patients compared to 66.7% in the standard-of-care group, representing an absolute risk reduction of 13.9%.
The FDA's filing of the PMA application initiates the substantive review phase of the PMA process. Spectral will continue to work closely with the Agency throughout the review and will provide updates as appropriate.
**About the Tigris Trial**
Tigris was a confirmatory Phase 3 study evaluating PMX in addition to standard care versus standard care alone in adult patients with endotoxic septic shock and elevated endotoxin activity levels measured using EAA™. The trial was designed as a 2:1 randomized study of 150 patients utilizing a Bayesian statistical framework.
As previously reported, the adjusted analyses demonstrated:
* 95.3% probability of benefit for 28-day all-cause mortality;
* Greater than 99% probability of benefit for 90-day mortality; and
* A favorable safety profile consistent with prior PMX studies and clinical experience.
\-----------------------------------------Some posts from Stockhouse board--------------------
My total guess is we get an FDA Decision by November 27, 2026.  There are NO Safety issues with PMX, Zero as far as I know and PMX has been in use for over 20 years.  SPECTRAL having been before the FDA so many times, the staff there are very familiar with the product.  IMO I don't see how the FDA does Not Approve this. 
I mean Eli Lilly's Drug XIGRIS which was approved by the FDA, has major Safety issues such as major bleeding, gastrointestinal issues and Brain Hemorrhages, amongst other things.  Yet the FDA approved the Drug and it was only removed from the Market in 2011, when Eli Lilly admitted subsequent clinical trials showed NO Survival Benefit.  Whereas today, it looks like SPECTRAL has shown a 17% survival benefit.  So my question is, if XIGRIS got approved, with all its problems and Zero Benefit, how can SPECTRAL not be approved ?  Therein lies the question.  I would have thought VANTIVE would have bought Spectral by now.  Oh well, I hope it gets approved.  This is OPINION NOT ADVICE and good luck everyone.
\----------------------------------------------------------------------------------------------------------
I'd take a smidge less than 2Billion for a buyout today, versus a full 2Billion valuation upon FDA approval.  I think the ball is mostly in Vantive's court on that matter.  Vantive has by far the most to gain by hooking up with Spectral because it's pure symbiosis to combine PMX/EAA with Vantive's Prismax. 

Spectral owns the only high margin razor blade and Vantive owns the low margin "handle" that PMX fits onto.  And Vantive will also gain exclusive profits to all of the necessary accouterments such as disposable tubing, fitings, clamps, service contracts, etc., which have a pretty decent margin. Plus it will allow Vantive to increase their 50% market dominance of Prismax towards 60% and beyond, because once PMX becomes part of the SOC, no hospital in America will upgrade their CRRT machines to a machine that can't accomodate this new treatment paradigm that will save little Jimmy's beloved grandpa.    

In my opinion, Carlyle Group will never be able to IPO their low margin dinosaur without Spectral in their stable.  Again, in my opinion as of today, Spectral would only entertain a buyout offer of $4 usd, and upon FDA approval, that number will rise to $5 usd or higher, depending on how quickly all USA hospitals will adopt the new SOC that is clearly coming. 

I could actually see hospitals today, that don't have a Prismax CRRT machine, taking into acount that this new treatment shift is about to become part of the SOC, and they need to be ready for it.  Any hospital in the current yearly sales cycle for a new CRRT machine upgrade, especially the one's that currently use a Braun, Fressenius, Takeda, or Nikkiso CRRT machine, in other words "the other 50%," will definitely have this in their mind, and if they don't, I'm certain the Vantive sales reps will remind them of it in their bid proposals. 

FYI I have a large position in this puppy.
Expect it to at least triple when it gets FDA approval from takeout offer. Just got FDA acceptance for filing of their PMA application. Spectral Medical Inc. focuses on the development and commercialization of products for the treatment of septic shock in the United States, Italy, Ireland, Russia, and internationally. Their Chief Medical Officer is [John Kellum](https://www.linkedin.com/in/john-kellum-306b692b1/) a world renown leader in critical care medicine with pioneering contributions to sepsis research, acute kidney injury, biomarkers, and precision-guided approaches to patient care.
# Spectral Medical Announces U.S. FDA Filing of PMA Application for PMX
[T.EDT](https://stockhouse.com/companies/quote?symbol=t.edt) | June 25, 2026
TORONTO, June 25, 2026 (GLOBE NEWSWIRE) -- **Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT),** a late-stage theranostic company advancing therapeutic options for sepsis and septic shock, today announced that the U.S. Food and Drug Administration (“FDA”) has completed its filing review and formally filed the Company's Premarket Approval (“PMA”) application for PMX, the Company’s endotoxin removal therapy for patients with endotoxic septic shock (“ESS”).
FDA acceptance for filing of the PMA application follows completion of the Agency's filing review process and confirms that the application contains all the information needed to proceed with the substantive review. The PMA application includes clinical, non-clinical, manufacturing and quality system information supporting the use of PMX in adult patients with ESS identified using Spectral’s FDA-cleared Endotoxin Activity Assay (“EAA™”).
“The FDA’s filing of our PMA application represents a defining milestone for Spectral and reflects years of focused clinical, regulatory and operational execution,” said Chris Seto, Chief Executive Officer of Spectral. “We believe the totality of evidence supporting PMX demonstrates the potential for a targeted therapy approach in endotoxic septic shock, an area of critical unmet medical need with limited therapeutic innovation over the past several decades. We have worked closely with the FDA throughout the PMA process and have been deliberate in assembling what we believe is a complete and compliant application. We look forward to continuing our engagement with the Agency during the review process.”
John A. Kellum, Chief Medical Officer of Spectral, added, “Endotoxic septic shock remains one of the most challenging conditions encountered in critical care medicine, with persistently high mortality despite advances in supportive care. The Tigris trial further strengthens the clinical evidence supporting PMX and the importance of identifying patients with elevated endotoxin activity using EAA™. We are grateful to the investigators, research coordinators and patients who participated in the clinical development of PMX and helped advance this important work. We are encouraged to have reached this important stage of the regulatory process.”
As previously announced, the Tigris trial met its pre-specified primary endpoint, demonstrating a 95.3% probability of benefit for 28-day all-cause mortality in the adjusted analysis, as well as a greater than 99% probability of benefit at 90 days. Complete results of Tigris trial out to 90 days were published in March of this year in the journal *The Lancet Respiratory Medicine.* The full Bayesian analysis of Tigris revealed an absolute risk reduction for mortality of 10.3% at 28 days corresponding to a number needed to treat (NNT) to prevent one death of 9.7 and 15.5% at 90-days corresponding to a NNT of 6.5. Long-term follow-up demonstrated that the survival benefit observed at 90 days persisted through 12 months, with mortality rates of 52.8% in PMX-treated patients compared to 66.7% in the standard-of-care group, representing an absolute risk reduction of 13.9%.
The FDA's filing of the PMA application initiates the substantive review phase of the PMA process. Spectral will continue to work closely with the Agency throughout the review and will provide updates as appropriate.
**About the Tigris Trial**
Tigris was a confirmatory Phase 3 study evaluating PMX in addition to standard care versus standard care alone in adult patients with endotoxic septic shock and elevated endotoxin activity levels measured using EAA™. The trial was designed as a 2:1 randomized study of 150 patients utilizing a Bayesian statistical framework.
As previously reported, the adjusted analyses demonstrated:
* 95.3% probability of benefit for 28-day all-cause mortality;
* Greater than 99% probability of benefit for 90-day mortality; and
* A favorable safety profile consistent with prior PMX studies and clinical experience.
\-----------------------------------------Some posts from Stockhouse board--------------------
My total guess is we get an FDA Decision by November 27, 2026.  There are NO Safety issues with PMX, Zero as far as I know and PMX has been in use for over 20 years.  SPECTRAL having been before the FDA so many times, the staff there are very familiar with the product.  IMO I don't see how the FDA does Not Approve this. 
I mean Eli Lilly's Drug XIGRIS which was approved by the FDA, has major Safety issues such as major bleeding, gastrointestinal issues and Brain Hemorrhages, amongst other things.  Yet the FDA approved the Drug and it was only removed from the Market in 2011, when Eli Lilly admitted subsequent clinical trials showed NO Survival Benefit.  Whereas today, it looks like SPECTRAL has shown a 17% survival benefit.  So my question is, if XIGRIS got approved, with all its problems and Zero Benefit, how can SPECTRAL not be approved ?  Therein lies the question.  I would have thought VANTIVE would have bought Spectral by now.  Oh well, I hope it gets approved.  This is OPINION NOT ADVICE and good luck everyone.
\----------------------------------------------------------------------------------------------------------
I'd take a smidge less than 2Billion for a buyout today, versus a full 2Billion valuation upon FDA approval.  I think the ball is mostly in Vantive's court on that matter.  Vantive has by far the most to gain by hooking up with Spectral because it's pure symbiosis to combine PMX/EAA with Vantive's Prismax. 
Spectral owns the only high margin razor blade and Vantive owns the low margin "handle" that PMX fits onto.  And Vantive will also gain exclusive profits to all of the necessary accouterments such as disposable tubing, fitings, clamps, service contracts, etc., which have a pretty decent margin. Plus it will allow Vantive to increase their 50% market dominance of Prismax towards 60% and beyond, because once PMX becomes part of the SOC, no hospital in America will upgrade their CRRT machines to a machine that can't accomodate this new treatment paradigm that will save little Jimmy's beloved grandpa.    
In my opinion, Carlyle Group will never be able to IPO their low margin dinosaur without Spectral in their stable.  Again, in my opinion as of today, Spectral would only entertain a buyout offer of $4 usd, and upon FDA approval, that number will rise to $5 usd or higher, depending on how quickly all USA hospitals will adopt the new SOC that is clearly coming. 
I could actually see hospitals today, that don't have a Prismax CRRT machine, taking into acount that this new treatment shift is about to become part of the SOC, and they need to be ready for it.  Any hospital in the current yearly sales cycle for a new CRRT machine upgrade, especially the one's that currently use a Braun, Fressenius, Takeda, or Nikkiso CRRT machine, in other words "the other 50%," will definitely have this in their mind, and if they don't, I'm certain the Vantive sales reps will remind them of it in their bid proposals. 

FYI I have a large position in this puppy.
Expect it to at least triple when it gets FDA approval from takeout offer. Just got FDA acceptance for filing of their PMA application. Spectral Medical Inc. focuses on the development and commercialization of products for the treatment of septic shock in the United States, Italy, Ireland, Russia, and internationally. Their Chief Medical Officer is [John Kellum](https://www.linkedin.com/in/john-kellum-306b692b1/) a world renown leader in critical care medicine with pioneering contributions to sepsis research, acute kidney injury, biomarkers, and precision-guided approaches to patient care.
# Spectral Medical Announces U.S. FDA Filing of PMA Application for PMX
[T.EDT](https://stockhouse.com/companies/quote?symbol=t.edt) | June 25, 2026
TORONTO, June 25, 2026 (GLOBE NEWSWIRE) -- **Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT),** a late-stage theranostic company advancing therapeutic options for sepsis and septic shock, today announced that the U.S. Food and Drug Administration (“FDA”) has completed its filing review and formally filed the Company's Premarket Approval (“PMA”) application for PMX, the Company’s endotoxin removal therapy for patients with endotoxic septic shock (“ESS”).
FDA acceptance for filing of the PMA application follows completion of the Agency's filing review process and confirms that the application contains all the information needed to proceed with the substantive review. The PMA application includes clinical, non-clinical, manufacturing and quality system information supporting the use of PMX in adult patients with ESS identified using Spectral’s FDA-cleared Endotoxin Activity Assay (“EAA™”).
“The FDA’s filing of our PMA application represents a defining milestone for Spectral and reflects years of focused clinical, regulatory and operational execution,” said Chris Seto, Chief Executive Officer of Spectral. “We believe the totality of evidence supporting PMX demonstrates the potential for a targeted therapy approach in endotoxic septic shock, an area of critical unmet medical need with limited therapeutic innovation over the past several decades. We have worked closely with the FDA throughout the PMA process and have been deliberate in assembling what we believe is a complete and compliant application. We look forward to continuing our engagement with the Agency during the review process.”
John A. Kellum, Chief Medical Officer of Spectral, added, “Endotoxic septic shock remains one of the most challenging conditions encountered in critical care medicine, with persistently high mortality despite advances in supportive care. The Tigris trial further strengthens the clinical evidence supporting PMX and the importance of identifying patients with elevated endotoxin activity using EAA™. We are grateful to the investigators, research coordinators and patients who participated in the clinical development of PMX and helped advance this important work. We are encouraged to have reached this important stage of the regulatory process.”
As previously announced, the Tigris trial met its pre-specified primary endpoint, demonstrating a 95.3% probability of benefit for 28-day all-cause mortality in the adjusted analysis, as well as a greater than 99% probability of benefit at 90 days. Complete results of Tigris trial out to 90 days were published in March of this year in the journal *The Lancet Respiratory Medicine.* The full Bayesian analysis of Tigris revealed an absolute risk reduction for mortality of 10.3% at 28 days corresponding to a number needed to treat (NNT) to prevent one death of 9.7 and 15.5% at 90-days corresponding to a NNT of 6.5. Long-term follow-up demonstrated that the survival benefit observed at 90 days persisted through 12 months, with mortality rates of 52.8% in PMX-treated patients compared to 66.7% in the standard-of-care group, representing an absolute risk reduction of 13.9%.
The FDA's filing of the PMA application initiates the substantive review phase of the PMA process. Spectral will continue to work closely with the Agency throughout the review and will provide updates as appropriate.
**About the Tigris Trial**
Tigris was a confirmatory Phase 3 study evaluating PMX in addition to standard care versus standard care alone in adult patients with endotoxic septic shock and elevated endotoxin activity levels measured using EAA™. The trial was designed as a 2:1 randomized study of 150 patients utilizing a Bayesian statistical framework.
As previously reported, the adjusted analyses demonstrated:
* 95.3% probability of benefit for 28-day all-cause mortality;
* Greater than 99% probability of benefit for 90-day mortality; and
* A favorable safety profile consistent with prior PMX studies and clinical experience.
\-----------------------------------------Some posts from Stockhouse board--------------------
My total guess is we get an FDA Decision by November 27, 2026.  There are NO Safety issues with PMX, Zero as far as I know and PMX has been in use for over 20 years.  SPECTRAL having been before the FDA so many times, the staff there are very familiar with the product.  IMO I don't see how the FDA does Not Approve this. 
I mean Eli Lilly's Drug XIGRIS which was approved by the FDA, has major Safety issues such as major bleeding, gastrointestinal issues and Brain Hemorrhages, amongst other things.  Yet the FDA approved the Drug and it was only removed from the Market in 2011, when Eli Lilly admitted subsequent clinical trials showed NO Survival Benefit.  Whereas today, it looks like SPECTRAL has shown a 17% survival benefit.  So my question is, if XIGRIS got approved, with all its problems and Zero Benefit, how can SPECTRAL not be approved ?  Therein lies the question.  I would have thought VANTIVE would have bought Spectral by now.  Oh well, I hope it gets approved.  This is OPINION NOT ADVICE and good luck everyone.
\----------------------------------------------------------------------------------------------------------
I'd take a smidge less than 2Billion for a buyout today, versus a full 2Billion valuation upon FDA approval.  I think the ball is mostly in Vantive's court on that matter.  Vantive has by far the most to gain by hooking up with Spectral because it's pure symbiosis to combine PMX/EAA with Vantive's Prismax. 

Spectral owns the only high margin razor blade and Vantive owns the low margin "handle" that PMX fits onto.  And Vantive will also gain exclusive profits to all of the necessary accouterments such as disposable tubing, fitings, clamps, service contracts, etc., which have a pretty decent margin. Plus it will allow Vantive to increase their 50% market dominance of Prismax towards 60% and beyond, because once PMX becomes part of the SOC, no hospital in America will upgrade their CRRT machines to a machine that can't accomodate this new treatment paradigm that will save little Jimmy's beloved grandpa.    

In my opinion, Carlyle Group will never be able to IPO their low margin dinosaur without Spectral in their stable.  Again, in my opinion as of today, Spectral would only entertain a buyout offer of $4 usd, and upon FDA approval, that number will rise to $5 usd or higher, depending on how quickly all USA hospitals will adopt the new SOC that is clearly coming. 

I could actually see hospitals today, that don't have a Prismax CRRT machine, taking into acount that this new treatment shift is about to become part of the SOC, and they need to be ready for it.  Any hospital in the current yearly sales cycle for a new CRRT machine upgrade, especially the one's that currently use a Braun, Fressenius, Takeda, or Nikkiso CRRT machine, in other words "the other 50%," will definitely have this in their mind, and if they don't, I'm certain the Vantive sales reps will remind them of it in their bid proposals.