1) Looks like an equity raise is happening. Details still not solidified: https://www.sedar.com/GetFile.do?lang=EN&docClass=9&issuerNo=00002006&issuerType=03&projectNo=03026048&docId=46784181) What are your thoughts on SQI Diagnostics? Saw some posts about it. Another tightly held Canadian biotech play.
There is a bit of a power play happening by an outside group who was looking to finance the pump side of the company.
Huge amounts were sold the day the baxter news came out.
Check out stockhouse.com. ...I think a group who has financed other deal wanted to do a financing with warrants and it backfired.
I'm buying more...fucking penny stocks.
Huge amounts were sold the day the baxter news came out.
Check out stockhouse.com. ...I think a group who has financed other deal wanted to do a financing with warrants and it backfired.
I'm buying more...fucking penny stocks.
They withdrawn the public offering today..I think they had to with this shit storm brewing.
I look at this as an opportunity across the market..I may even buy a bit more here.
I still think this will win it's just going to be brutal for a bit.
I hope all you fellas are doing okay out there despite the ugly situation.
I look at this as an opportunity across the market..I may even buy a bit more here.
I still think this will win it's just going to be brutal for a bit.
I hope all you fellas are doing okay out there despite the ugly situation.
Tablo gets FDA approval on a 30 person trial, pumps are in need right now because of some part of c 19 treatment and because of the risk of infections within dialysis centers.
The Tablo machine is the Rolls Royce of HD machines and won't be favored by insurance companies.
We have the Toyota Corolla of machines affordable, reliable and pretty much market ready.
Why not? the timing works and The FDA is playing ball.
https://www.massdevice.com/outset-medical-at-home-dialysis-system-wins-fda-approval/
Also I wouldn't doubt the cartridge isn't getting some looks as C19 end of life times and sepsis are connected.
I have an offer in today for another 20K
The Tablo machine is the Rolls Royce of HD machines and won't be favored by insurance companies.
We have the Toyota Corolla of machines affordable, reliable and pretty much market ready.
Why not? the timing works and The FDA is playing ball.
https://www.massdevice.com/outset-medical-at-home-dialysis-system-wins-fda-approval/
Also I wouldn't doubt the cartridge isn't getting some looks as C19 end of life times and sepsis are connected.
I have an offer in today for another 20K
[h=3]Spot on post from another board..
RE:Is it the good time to invest in Spectral Medical!?[/h]Kab!
There are a few irons in the fire, one of which I am hoping is an uptick to a higher level of the NASDAQ. Unfortunately, if that is/was the plan, the Pandemic afforded an opportunity to be noticed but alas they haven't performed (YET!) the required diligence to do so. Maybe over the nenxt few months we could see that happen. A MISSED OPPORTUNITY, imo, because the News today was on very few investors' radars. Had it been on a higher exchange, we coulda/woulda/shoulda seen $2 easy.
The EAA/PMX combination will be a game changer once the 3b trial is over. Now being a Phase 3 trial means they have jumped a lot of hoops, so far and dtaes have been pushed back years to get to this point. You gotta wonder with so many dying of Sepsis over the years, how many lives could have been saved with the knowledge that has been procured from the data.
SAMI/DIMI will bring in sales/revenues that will make us a lot of money as well as shareholders.
Get in nowand I'll be surprised if you don't make 400% over the next year. IMHO
RE:Is it the good time to invest in Spectral Medical!?[/h]Kab!
There are a few irons in the fire, one of which I am hoping is an uptick to a higher level of the NASDAQ. Unfortunately, if that is/was the plan, the Pandemic afforded an opportunity to be noticed but alas they haven't performed (YET!) the required diligence to do so. Maybe over the nenxt few months we could see that happen. A MISSED OPPORTUNITY, imo, because the News today was on very few investors' radars. Had it been on a higher exchange, we coulda/woulda/shoulda seen $2 easy.
The EAA/PMX combination will be a game changer once the 3b trial is over. Now being a Phase 3 trial means they have jumped a lot of hoops, so far and dtaes have been pushed back years to get to this point. You gotta wonder with so many dying of Sepsis over the years, how many lives could have been saved with the knowledge that has been procured from the data.
SAMI/DIMI will bring in sales/revenues that will make us a lot of money as well as shareholders.
Get in nowand I'll be surprised if you don't make 400% over the next year. IMHO
DVA and BAX have lost very little price off of their highs; Compared to other stock. I still like them, i buy KO and PEP and MCD and MDLZ to give people diabetes, DVA and BAX to help them control their diabetes.
I am definitely intrigued by the dialysis play for two reasons.
1. The amount of money spent on dialysis every year in the USA
2. Rule changes that will allow patients to get the government to pay for it using a machine in their home.
Those two factors seem to tell me there is going to be a ton of money made by someone....why not me.
I called a friend of mine that is a nephrologist to get his take on it. I think he works for Fresenius. He didnt have any real earth shattering info other than he can see the in-home market take off. Also the number of doctors entering the field is dropping all the time. So any kind of product that can reduce the doctor side of the care will definitely be needed.
With that said and going through the thread. Who are the most likely to become players in the market in terms of coming up with an affordable dialysis machine for in home? Or maybe it hasnt emerged far enough yet.
1. The amount of money spent on dialysis every year in the USA
2. Rule changes that will allow patients to get the government to pay for it using a machine in their home.
Those two factors seem to tell me there is going to be a ton of money made by someone....why not me.
I called a friend of mine that is a nephrologist to get his take on it. I think he works for Fresenius. He didnt have any real earth shattering info other than he can see the in-home market take off. Also the number of doctors entering the field is dropping all the time. So any kind of product that can reduce the doctor side of the care will definitely be needed.
With that said and going through the thread. Who are the most likely to become players in the market in terms of coming up with an affordable dialysis machine for in home? Or maybe it hasnt emerged far enough yet.
[h=3]Report From Paradigm Capital on EDT[/h]
Joining the Fight Against COVID-19
Investment Thesis. Spectral Medical is a clinical-stage medical device company focused on addressing significant needs in critical care. Its lead product is PMX, a therapy that filters septic shock-causing endotoxins from the blood. While PMX has been used for 20 years in Japan and Europe, EDT is performing the trials required for FDA approval and commercial launch in the US. Septic shock is the leading cause of death in hospitals and impacts 330,000 American patients a year. EDT is currently running a Phase 3b trial of PMX that, if successful, would make it the only FDA-approved treatment for septic shock patients, and the only player in an over $2B market.
Event
Spectral Medical announced that the FDA has approved a supplemental Investigational Device Exemption (IDE) for the use of PMX in treating COVID-19 patients.
Highlights
Immediate Benefit for Severe COVID-19 Patients | This supplemental IDE will allow physicians to treat severe COVID-19 patients with the PMX blood filtration device. Published reports of COVID-19 patient outcomes have highlighted that septic shock is a leading complication from COVID-19, contributing to excess inflammation and organ damage [Lancet][NEJM]. As with EDT’s non-COVID-19 patients, these patients will be some of the most severe in the ICU and experiencing multiple organ failure. EDT is not charging for the PMX cartridges and won’t have significant costs to roll out this program, so the major impact in the near term will be to patients. Leveraging Extensive Clinical Use | PMX has been used across Japan and Europe for 20 years in treating severe critical care patients. Spectral has significantly expanded the clinical data on PMX with its prior Phase 3 trial, demonstrating significant reductions in ventilator use and reduced 28-day mortality for septic shock patients with multiple organ failure and endotoxin levels from 0.6 to 0.9 [Intensive Care Med]. There are also published case reports of PMX improving blood oxygen levels and other outcomes in patients with other respiratory viral infections, including H1N1 and H5N1 [Intensive Care Med]. Therefore, considering the array of drugs and devices that are being used to treat COVID-19 patients, PMX has a strong history of clinical benefit. Increased U.S. Awareness Could Accelerate Market Uptake | Longer term, this program could provide significant exposure for the company and the PMX treatment. If the ongoing Phase 3b trial is eventually successful and PMX is approved by the FDA, it will have more physicians who have used the therapy and seen its benefits, potentially accelerating uptake.
Valuation & Conclusion
COVID-19 is highlighting the need for effective treatments for excessive inflammation, including septic shock. This announcement means that EDT will have the opportunity to make a significant impact on COVID-19 patients’ lives while increasing the U.S. exposure for its PMX therapy. The company is also awaiting similar authorization in Canada for use in COVID-19 patients. We reiterate our Buy rating and $4.00 rNPV.
Joining the Fight Against COVID-19
Investment Thesis. Spectral Medical is a clinical-stage medical device company focused on addressing significant needs in critical care. Its lead product is PMX, a therapy that filters septic shock-causing endotoxins from the blood. While PMX has been used for 20 years in Japan and Europe, EDT is performing the trials required for FDA approval and commercial launch in the US. Septic shock is the leading cause of death in hospitals and impacts 330,000 American patients a year. EDT is currently running a Phase 3b trial of PMX that, if successful, would make it the only FDA-approved treatment for septic shock patients, and the only player in an over $2B market.
Event
Spectral Medical announced that the FDA has approved a supplemental Investigational Device Exemption (IDE) for the use of PMX in treating COVID-19 patients.
Highlights
Immediate Benefit for Severe COVID-19 Patients | This supplemental IDE will allow physicians to treat severe COVID-19 patients with the PMX blood filtration device. Published reports of COVID-19 patient outcomes have highlighted that septic shock is a leading complication from COVID-19, contributing to excess inflammation and organ damage [Lancet][NEJM]. As with EDT’s non-COVID-19 patients, these patients will be some of the most severe in the ICU and experiencing multiple organ failure. EDT is not charging for the PMX cartridges and won’t have significant costs to roll out this program, so the major impact in the near term will be to patients. Leveraging Extensive Clinical Use | PMX has been used across Japan and Europe for 20 years in treating severe critical care patients. Spectral has significantly expanded the clinical data on PMX with its prior Phase 3 trial, demonstrating significant reductions in ventilator use and reduced 28-day mortality for septic shock patients with multiple organ failure and endotoxin levels from 0.6 to 0.9 [Intensive Care Med]. There are also published case reports of PMX improving blood oxygen levels and other outcomes in patients with other respiratory viral infections, including H1N1 and H5N1 [Intensive Care Med]. Therefore, considering the array of drugs and devices that are being used to treat COVID-19 patients, PMX has a strong history of clinical benefit. Increased U.S. Awareness Could Accelerate Market Uptake | Longer term, this program could provide significant exposure for the company and the PMX treatment. If the ongoing Phase 3b trial is eventually successful and PMX is approved by the FDA, it will have more physicians who have used the therapy and seen its benefits, potentially accelerating uptake.
Valuation & Conclusion
COVID-19 is highlighting the need for effective treatments for excessive inflammation, including septic shock. This announcement means that EDT will have the opportunity to make a significant impact on COVID-19 patients’ lives while increasing the U.S. exposure for its PMX therapy. The company is also awaiting similar authorization in Canada for use in COVID-19 patients. We reiterate our Buy rating and $4.00 rNPV.
There is only one other player that I know of with a machine close to being ready...
https://www.politico.com/news/2020/04/15/dialysis-kidney-coronavirus-188840
[h=3][FONT="]From [/FONT][FONT=Helvetica Neue, Helvetica, Roboto, Arial, sans-serif]Stockhouse [/FONT]
[FONT="]RE:RE
IMI[/FONT][/h]Baxter is now the exclusive Distributor of PMX and the EAA in NA
Baxter is one of, if not THE, largest medical equipment & supplies vendor to US Hospitals (in particular ICUs)
Baxter is very likely accutely aware of the urgent need for dialysis supplies and the fact that very soon, CRRT machines will become scarce (perhaps as much or moreso, than are ventilators).
PMX treatments reduce reliance on ventilators.
Baxter is aware that Spectral has an FDA approved portable pump (for use in BOTH hemopurfusion and CRRT), and has exclusive world wide rights. Imagine the advantage of dual use, easy to operate, portable pump equipment?
Baxter is aware that Spectral has a HD pump, that is very close to getting FDA approval.
Baxter likely has great manufacturing, ramp up connections.
Baxter wants to get back into the HD business - and this form of in-home treatment has been singled out (in 2019) as an area that Trump wants to promote (both to save costs and to produce better outcomes). The need is now even more urgent given Covid and the need for more social distancing, especialy for dialysis patients who tend to have other risk factors. There is also a need to migrate non-covid treatments outside of the overwhelmed hospital settings.
Baxter, I would dare say, is a logical buyer of Spectral, if and when PMX is FDA apporved (or maybe before depending on how it performs (wrt Covid) perhaps even prior to interim data release
Baxter has strong connections to the FDA.
It doesn't take a rocket scientist, or a Harvard MBA, to guess that an outright purchase of Spectral (and ALL of its wares) has been (is being?) contemplated very seriously by Baxter.
Or not. There I said it !
MM
[FONT="]RE:RE
IMI[/FONT][/h]Baxter is now the exclusive Distributor of PMX and the EAA in NABaxter is one of, if not THE, largest medical equipment & supplies vendor to US Hospitals (in particular ICUs)
Baxter is very likely accutely aware of the urgent need for dialysis supplies and the fact that very soon, CRRT machines will become scarce (perhaps as much or moreso, than are ventilators).
PMX treatments reduce reliance on ventilators.
Baxter is aware that Spectral has an FDA approved portable pump (for use in BOTH hemopurfusion and CRRT), and has exclusive world wide rights. Imagine the advantage of dual use, easy to operate, portable pump equipment?
Baxter is aware that Spectral has a HD pump, that is very close to getting FDA approval.
Baxter likely has great manufacturing, ramp up connections.
Baxter wants to get back into the HD business - and this form of in-home treatment has been singled out (in 2019) as an area that Trump wants to promote (both to save costs and to produce better outcomes). The need is now even more urgent given Covid and the need for more social distancing, especialy for dialysis patients who tend to have other risk factors. There is also a need to migrate non-covid treatments outside of the overwhelmed hospital settings.
Baxter, I would dare say, is a logical buyer of Spectral, if and when PMX is FDA apporved (or maybe before depending on how it performs (wrt Covid) perhaps even prior to interim data release
Baxter has strong connections to the FDA.
It doesn't take a rocket scientist, or a Harvard MBA, to guess that an outright purchase of Spectral (and ALL of its wares) has been (is being?) contemplated very seriously by Baxter.
Or not. There I said it !
MM
Bozzie i wish you luck , Baxter is still the play for me.
Seems like it was foolish of me to try to grab a lower cost base from $0.74 (purchased in Jan). I still feel like the entire market is due for another big pullback and that was influencing my decision here.
That said, nervous to get caught with my pants down nickle and diming this long-term play as if it's a day trade.
Probbaly prudent to get back in, even if the broader economy forces a slide here.
