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  #326  
Old 03-10-2018, 03:09 PM
Bozzie Bozzie is offline
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Interesting read.
I wish i wasn't so superstitious.

Sepsis Detection Device Market to Be Driven by Rising Geriatric Population and High Incidence of Hospital-Acquired Infections - Press Release - Digital Journal
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  #327  
Old 03-10-2018, 04:55 PM
tigerman19 tigerman19 is offline
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Made it to page 14.
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  #328  
Old 03-10-2018, 05:38 PM
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Quote:
Originally Posted by tigerman19 View Post
Made it to page 14.
woot woot... it's the gambler in me

thanks Tman
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  #329  
Old 03-13-2018, 07:16 AM
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As the days go by if i have the opportunity to sell a little i would.

Just saying
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  #330  
Old 03-13-2018, 05:01 PM
tigerman19 tigerman19 is offline
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Shit....I'm not selling now. Lol.
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  #331  
Old 03-13-2018, 05:09 PM
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Yeah.. i have more than i want.
I'm not liking this delay at all after all this is a device without any side effects it shouldn't be this hard.
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  #332  
Old 03-13-2018, 11:00 PM
tigerman19 tigerman19 is offline
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I cut some loose a while back when it ran up to $.40. Sure as shit if I sell some I'll be kicking myself if we get good news. I kindof worked it a little after that big drop 2 October's ago.
I thought we were waiting on response back for the toramyxin cartridges. Thought we already had device approval. Did I read past articles wrong?
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  #333  
Old 03-14-2018, 09:34 AM
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The toramyxin cartridges are considered a device but the fact the membrane within the cartridge is coated with what i will call a protein makes it more complicated than just a straight device.
We are waiting on the FDA but the FDA has their own rules and are about to pass the expected date of completion.
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  #334  
Old 03-19-2018, 11:30 AM
tigerman19 tigerman19 is offline
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Ouch....
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  #335  
Old 03-19-2018, 12:02 PM
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Disappointing in the near term.
A post from stockhouse that i think is valid

Wait time vs probabilty.
Reading between the lines, and relying on my observations/opinions from today’s news and trading:

IMO the odds of approval just went up. Sounds to me like the FDA is looking for a face saving way to “approve” PMX in a more limited way, in view of a Primary endpoint miss, and yet still preserve the integrity of the RCT process that has been so long engrained in their approval system. The apparent out? –a request for more supplementary data, and or a smaller non RCT study.
There seems to be a willingness on the part of the FDA to give Spectral the benefit of the doubt, more than likely stemming from an overriding “unmet need”, and positive subgroup data and secondary endpoint positives. If it was otherwise it would have been a flat “ No”
Not clear the extent or amount of new data that will be required. Would have thought lots of real world data registries, etc. would have been sufficient. Were they presented and summarized appropriately? Or is there not sufficient data incorporating EAA and endotoxin levels – the cornerstone of the Spectral approach? Euphas 2 was supposed to provide some of that. Perhaps more is needed.
Share trading in the hundreds of thousands vs. millions. Suggests strong hands. There was a small battle between those who see the odds of approval now higher, vs. those that see it as “dead money” for the next little while. The long process thusfar, has attracted only the most patient of investors. Some of those took the opportunity to accumulate from the least patient, more risk adverse amoungst us.
I don’t rule out the possibility of a lower priced buy-out in the near term (before further FDA mandates). Depends on Spectral insiders level of exhaustion. Perhaps they pass the baton to a Company that has the $ and patience to see it through to completion (and who probably now believes there will be a much less onerous pathway to approval, and who believes that the odds are now squarely in favour of ultimate approval). Plus a new Company would have to put a value on the FDA approved SAM pump and EAA (both of which include worldwide rights).
Next course of action will be somewhat dependent on the potential for new cashflows. In the interim, the Company has to assess their ability to generate higher cashflows in the short term, in order to finance a “least burdensome” approach, that will be “substantially limited in cost and time lines”. E.g. loan from Toray, increased EAA Sales trend, Canadian PMX Sales, SAM pump revenues (CRRT in US, and Hemoperfusion worldwide), distributor advances, etc.
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  #336  
Old 03-19-2018, 08:43 PM
tigerman19 tigerman19 is offline
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Buying more on the cheap?
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  #337  
Old 03-19-2018, 10:53 PM
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Sold some at 38.5 not a ton but i have money to pick up some cheap once this drifts down some..i may try to sell a little more if it pops up tomorrow.

Still in but i think till the new study is announced there isn't much to get too excited about.
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  #338  
Old 01-09-2019, 06:45 PM
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This is still kicking.
The home dialysis pump they have is suddenly a commodity.
Home dialysis will be a 24 billion dollar market in the US by 2023 and a $124 billion world wide by 2023.

Hang on.. things could get interesting
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Last edited by Bozzie; 01-09-2019 at 06:50 PM.
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  #339  
Old 02-08-2019, 07:58 AM
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Strange trading on this the past week..big bids and asks.
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  #340  
Old 02-19-2019, 07:22 AM
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Good news..
These guys a prime for a take out now.
Holding 400k+ with crosses fingers






TORONTO, Feb. 19, 2019 (GLOBE NEWSWIRE) -- Spectral Medical Inc. (“Spectral” or the “Company”) (TSX:EDT), a Phase III company developing the first treatment for patients with endotoxemic septic shock guided by a companion diagnostic, today announced that the Tigris clinical trial has been approved by the US FDA as an amendment to the original EUPHRATES’s IDE and, as such it will add to the data from the EUPHRATES trial. Patients will be enrolled in the Tigris trial using the same eligibility criteria as those that showed a clinically significant mortality benefit within the EUPHRATES trial.

TIGRIS will use the same primary endpoint of 28 day mortality, is expected to enroll 150 septic shock patients with a MODS score >9 and Endotoxin Activity Assay (EAA) levels between 0.60 and 0.90, will be randomized 2:1 for treatment vs control arm and will be open label. The study will employ a Bayesian statistical approach to combine data from the EUPHRATES trial with data from the Tigris trial. Tigris will be run exclusively in US hospital sites experienced in using the PMX cartridge and who demonstrated a good enrollment rate in the EUPHRATES trial.

“The Company has been engaged in a detailed interactive process with the US FDA to determine the optimal pathway forward with the Toraymyxin™ (“PMX”) cartridge,” said Dr Paul Walker, President and CEO of Spectral. “We are pleased with the guidance from the US FDA, and are confident in the program we have designed to demonstrate efficacy and safety to support a future application for approval of this potentially lifesaving treatment. The incidence of sepsis and septic shock continues to rise in the United States and continues to carry an unacceptably high mortality rate, which in this patient group has been shown to be in excess of 40%.

We anticipate that the Tigris trial will begin enrollment in the near future, and will provide necessary efficacy and safety confirmatory data for the use of Toryamyxin (PMX) in septic shock patients. Identifying patients most likely to respond to this treatment based on knowledge gained from the EUPHRATES trial remains a unique aspect of this trial. The EUPHRATES trial demonstrated that when the endotoxin activity was in the critical treatment range of 0.6 to 0.9 a clinical benefit of mortality reduction and improvement in organ function was seen. The EAA remains the only assay cleared by the FDA for measurement of endotoxin activity.

The US FDA has also recently reviewed a new special 510(k) submission for the EAA, wherein the company upgraded some of the assay features including *****ous data in support of the sensitivity and reliability of the assay at the 0.9 EA units cut-off.

About the EUPHRATES Trial

The EUPHRATES trial was a prospective double blinded trial design to assess safety and effectiveness of the PMX treatment in patient with endotoxemic septic shock. Although, overall, the trial did not show a mortality benefit, a subgroup was identified that had a clinically significant mortality benefit when treated with the PMX cartridge. The data showed that for patients with high levels of endotoxin activity in the range of 0.60 to 0.90 EA units and that received the full dose of the PMX cartridge exposure, there was a mortality benefit, (absolute reduction in mortality of 10.7% a 30% relative risk reduction), as well as important secondary endpoints related to organ function (days alive and free of mechanical ventilation and renal support). These finding were published in the November issue of Intensive Care Medicine.

About Spectral

Spectral is a Phase III 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 US FDA cleared diagnostic for the risk of developing sepsis.

PMX has been approved for therapeutic use in Japan, Europe and Asia and has been used safely and effectively on more than 150,000 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 350,000 patients are diagnosed with severe sepsis and septic shock in North America each year. Spectral is listed on the Toronto Stock Exchange under the symbol EDT. For more information please visit Spectral Medical Inc. The first theranostic approach to Sepsis.

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 and clinical trials, 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, general economic, market and business conditions, as well as other risks and uncertainties which are more fully described in Spectral’s Annual Information Form dated March 28, 2018, and in other filings of Spectral with securities and regulatory authorities which are available at Welcome to the SEDAR Web Site / Bienvenue au Site Web SEDAR. Spectral does not undertake any obligation to update forward-looking statements should these assumptions change. Nothing in this document should be construed as either an offer to sell or a solicitation to buy or sell Spectral securities.
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Last edited by Bozzie; 02-19-2019 at 07:23 AM.
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  #341  
Old 04-12-2019, 11:09 AM
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Interesting new IR up on the company site.
The pump is worth $$$ suddenly.
If you have the time a money to wait this out it will pay soon enough.

http://www.spectraldx.com/assets/spe..._april2019.pdf

Last edited by Bozzie; 04-12-2019 at 11:13 AM.
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  #342  
Old 04-16-2019, 12:38 PM
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Nxstage just sold their pump for 2 billion.

Here is the Spectral pump that is sold in Europe under a different name produced by spectral partner in the pump Infomed

dimi.swiss
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  #343  
Old 05-10-2019, 04:08 PM
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Decent history of the company and where they are now.

Stockhouse privacy policy (version 1)
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