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  #76  
Old 04-12-2016, 08:15 PM
tigerman19 tigerman19 is online now
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I been buying too. Hopefully, it'll pan out. Would benefit us financially but really sounds like an excellent product that will save lives. A lot of unnecessary loss of life from sepsis.
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  #77  
Old 04-14-2016, 12:34 AM
Bozzie Bozzie is offline
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Down to 15 left..nice mention in a Huffington article about sepsis.
If this gets the same numbers as the previous trails it's a slam dunk with the FDA and my feeling is this group has been targeting the right population for treatment.

I funded today to buy more as well, i expect a pop upon the trial completion in June.

Hopefully we all make some money.
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Last edited by Bozzie; 04-14-2016 at 12:37 AM.
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  #78  
Old 04-14-2016, 05:34 PM
hodge333 hodge333 is online now
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It would be great for this to get approved, we make some cash and most importantly of all lives are saved and changed because of this great treatment.
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  #79  
Old 04-22-2016, 01:42 AM
nutty_bar nutty_bar is offline
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I really wonder with this stock... Something tells me this stock isn't going anywhere. With all the hype about this company almost getting FDA approve for its sepsis treatment, and it's stock is still dead in the water with no movement and no interest from investors pushing up its price. Surely by now the price should be in an uptrend the last couple months with investors snatching up shares here and there and hoping to strike gold... But it's stock price hasn't gone anywhere. It's definitely a red flag here, be careful my maller friends. I've seen this situation far too many times in my 15 years of experience.
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  #80  
Old 04-22-2016, 12:27 PM
Bozzie Bozzie is offline
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As I've always said..this is a win all or lose all situation.

Check out CPXX in the 3rd phase with the FDA.
Nasdex listed and was trading at 1.76 three weeks ago , with positive news on their 3rd phase of their trial its now trading around 16.00.
My guess is there will be very positive news on completion of the trial and during the period between completion and the FDA decision a possible uplisting if price points can be held for nasdex requirements.

I'm just guessing on all of this but this company has been preparing for this moment for years and I believe there is a plan in place to uplist...the OTC is a crap market and many funds, and houses prohibit investment.
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Last edited by Bozzie; 04-22-2016 at 12:32 PM.
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  #81  
Old 04-26-2016, 06:06 PM
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Approval isn't in doubt any longer IMO.
20% absolute reduction in mortality is insanely good in the medical world for people this near death.

I'm buying while i still can.

Company update
http://spectraldx.com/assets/spectra...-march2016.pdf
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  #82  
Old 04-27-2016, 09:01 PM
capainter capainter is offline
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Good to hear Bozzie. I'll probably add this week.

What do you see as the ideal exit point? Announcement of trial results or not until FDA approval? Seems like getting this commercialized may be more difficult than getting it approved.
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  #83  
Old 04-28-2016, 01:03 AM
Bozzie Bozzie is offline
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This group isn't set up to commercialize and i doubt they have the desire, ability or cash to do what it would take to do it right . If approved I'd think someone will take them out, someone big with the ability and infrastructure to commercialize quickly.
I'm not sure when i will exit but my feeling is maximum price will be the take out price.
I'm going to be interested in what they have to say after the last module (trial results) are completed in late June. I'd expect a very bullish statement from what has been a super cautious and conservative group from the start.
I've been buying as well with the thought i will sell a little between the trail ending and the FDA processing the results.
I'm still amazed with the 20% absolute morality number and the life saving ability that basically translates into saving 1 out 3 people on deaths door.

This story is always encouraging
The Turning Point
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Last edited by Bozzie; 04-28-2016 at 01:30 AM.
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  #84  
Old 05-11-2016, 01:41 PM
nutty_bar nutty_bar is offline
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Prices has been creeping up nicely. Anticipating a spike in price in the near future.... I sense company insiders are starting to load up..
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  #85  
Old 05-21-2016, 01:22 PM
capainter capainter is offline
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Bozzie, all is looking good. Thinking about expanding my position from about $10k to about $30k in hopes of good news in June. Did I miss anything of note?
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  #86  
Old 05-21-2016, 02:08 PM
Bozzie Bozzie is offline
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No... everything looks on track to me.
I'd expect an announcement next week or just before the AGM on the 31st
Check your donation box.
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  #87  
Old 05-21-2016, 06:00 PM
tigerman19 tigerman19 is online now
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What was the run up couple weeks ago? I was hoping people smarter than me adding to their position but seems they dumped some off this week to take profit.
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  #88  
Old 05-21-2016, 06:07 PM
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We not gonna be in the next insider trading thread on main street, are we?
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  #89  
Old 05-21-2016, 07:03 PM
Bozzie Bozzie is offline
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Quote:
Originally Posted by tigerman19 View Post
We not gonna be in the next insider trading thread on main street, are we?


As long as i've been in this thing i only wish i knew something insiders might know. I bought so long ago its crazy
The company issued PR saying there would be a clinical update before the AGM on the 31st . If you believe the March investors update you would think positive news is coming our way.

I feel the sell off was people taking a profit, stock was up 40% off recent lows.


Phil should go to jail.
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  #90  
Old 05-21-2016, 10:19 PM
tigerman19 tigerman19 is online now
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First off I know this will only be your guess/opinion, but I have a couple questions for you boozie. You've said before you don't think this company has any intentions of mass producing the product. You feel they just will sellout to a huge pharmaceutical/medical device maker that is in better position to produce the product. Is this correct? Secondly, I've seen there are currently 220million outstanding shares. If they are bought out, does it mean that the buyout buys all those shares?
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  #91  
Old 05-21-2016, 11:32 PM
Bozzie Bozzie is offline
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I have no idea what will happen but i do know commercialization isn't what this company does, i'd guess either a partnership or deal eventually.
A buy out would be for all buddy,
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  #92  
Old 05-22-2016, 12:15 AM
tigerman19 tigerman19 is online now
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Ok. Thanks for your insight. That's what I thought just making sure.

I would again like to thank you for this opportunity. Unless they just go belly up in one day and cancel out any gains, I've already made nearly $20k here. I, at the very least, owe you a beer. Lol
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  #93  
Old 05-22-2016, 12:29 AM
Bozzie Bozzie is offline
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Originally Posted by tigerman19 View Post
Ok. Thanks for your insight. That's what I thought just making sure.

I would again like to thank you for this opportunity. Unless they just go belly up in one day and cancel out any gains, I've already made nearly $20k here. I, at the very least, owe you a beer. Lol


Dude that is awesome...lets keep it rolling!!!
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  #94  
Old 05-22-2016, 09:54 AM
capainter capainter is offline
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Yes. Many thanks Bozzie for the tip! Let's hope it hits big soon.
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  #95  
Old 05-22-2016, 12:31 PM
Bozzie Bozzie is offline
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Thank me if this hits buddy!

Good luck to us both.
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  #96  
Old 05-27-2016, 12:04 PM
Bozzie Bozzie is offline
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I was thinking they would release news this week, with the market closed Monday i'd guess Tuesday the company will update the clinical and relevant company news.
It is a bit strange the news will be released the same day as the AGM.
I'm hoping these guys finally get aggressive in getting the word out to the US buyers.
The last small push up in price was 100% Canadian driven and i think we all know the US investors appetite for a long shot investment.
Next week could be interesting.
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Last edited by Bozzie; 05-27-2016 at 12:24 PM.
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  #97  
Old 05-31-2016, 11:00 AM
Bozzie Bozzie is offline
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Nothing earth shattering in todays PR, sounds like the continued use program could start shortly and that could have a positive effect on the price.

Check out CPXX today.. looks like they are being bought out at $ 30.00 PS.





May 31, 2016 08:00 ET

Spectral Medical Files Expanded Access Protocol With FDA for Toraymyxin™ Septic Shock Treatment
Four patients remaining to enroll in the EUPHRATES clinical trial
Company expects to announce trial results and submit final PMA module before end of 2016
TORONTO, ONTARIO--(Marketwired - May 31, 2016) - Spectral Medical Inc. ("Spectral" or the "Company"), (TSX:EDT) (OTCQX:EDTXF), a Phase III Company advancing a precision treatment targeting specific patients at high risk of death from septic shock, today announced that it has filed a protocol and is in discussions with the U.S. Food and Drug Administration (FDA) for Expanded Access of Toraymyxin™, the Company's investigational therapeutic hemoperfusion device that removes endotoxin from the bloodstream. The Company also announced several significant updates and milestones achieved on its path to potential regulatory approval and anticipated commercial availability of its treatment in the United States.
The Expanded Access program, sometimes referred to as Compassionate Use, if approved by the FDA, would begin upon the completion of patient enrollment - expected no later than June 30, 2016 - at most of the 29 U.S. hospitals currently participating in the Phase III EUPHRATES clinical trial. Patients who meet the clinical criteria for septic shock, are in multiple organ failure and who have elevated levels of endotoxin in the blood, as measured by the Company's FDA cleared Endotoxin Activity Assay (EAA™), would be eligible for the treatment. A similar program is planned for Canada, where there are 12 hospitals engaged in the clinical trial.
"Currently, there is no approved treatment for patients in septic shock, the most advanced and lethal stage of sepsis, and clinicians are left with very few options to treat the sickest of patients," said Dr. Paul Walker, President and CEO of Spectral. "Toraymyxin™ represents a new solution for sepsis treatment and has been used on more than 150,000 patients outside of North America over the course of more than a decade. Provided the FDA approves our Expanded Access program, this treatment could be available soon for use in select patients at participating clinical trial locations in the United States."
Spectral also provided guidance today on several significant clinical and regulatory milestones:
As of today, only four patients remain to be enrolled in the EUPHRATES trial, which is fully on track to be completed by no later than June 30, 2016.

The FDA has accepted Spectral's statistical analysis plan for the PMA submission of Toraymyxin™. Subsequent to analysis of the trial data, the Company expects to announce primary end point results around the end of September 2016 and will then submit the last module of the PMA. The first three modules have already been submitted to the FDA. Assuming positive clinical data and barring any unexpected delays, Spectral anticipates a decision from the FDA as early as the first quarter of 2017.

The Company has submitted a 510K to the FDA for a proprietary stand-alone pump dedicated to the Toraymyxin™ therapy that would facilitate treatment delivery in the Intensive Care Unit (ICU) and increase options available to clinicians. The pump is also designed to provide an open platform for other hemoperfusion cartridges and to deliver continuous renal replacement therapy when indicated. A decision is expected in Q3 2016 and, if approved, the pump will be available for use in the Expanded Access program where needed.

In anticipation of potential FDA approval of Toraymyxin™, Spectral and Toray Industries Inc. (Toray) are both taking the necessary operational steps to scale up manufacturing capabilities in order to be ready to begin sales in the first half of 2017. A new plant has been built by Toray in Japan for the manufacture of Toraymyxin™ and EAA™ manufacturing capacity has been expanded in Toronto. The Company is also currently engaged in confidential discussions with potential interested partners that have existing sales and marketing infrastructures and it will be evaluating all potential options going forward.
"The progress we have demonstrated so far represents the culmination of six years of diligent work on clinical, regulatory and commercialization programs to bring the first approved product for endotoxemic septic shock to market and the finish line is in sight," added Dr. Paul Walker. "The imminent completion of patient enrollment in the EUPHRATES trial is an important step that brings Spectral significantly closer to addressing an enormous unmet medical need."
Over 1,000,000 patients are diagnosed with sepsis in the United States each year and over 300,000 of these patients die annually despite best practices employed by critical care and intensive care unit hospital staff.
About Spectral Medical Inc.
Spectral is a Phase III company seeking U.S. FDA approval for its lead theranostics product for the treatment of endotoxemic septic shock. Toraymyxin™ (PMX) is a therapeutic hemoperfusion device that removes endotoxin, a main trigger of sepsis and septic shock, from the bloodstream. Directed by the Company's Endotoxin Activity Assay (EAA™), the only FDA cleared diagnostic for the risk of developing sepsis, Spectral's EUPHRATES trial is the world's only active and most innovative Phase III study for a medical device in the area of septic shock.
PMX has been approved for therapeutic use in Japan and Europe, and has been used 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. Over 350,000 patients are diagnosed with septic shock in North America each year, representing a greater than $3 billion market opportunity for Spectral.
Spectral is listed on the Toronto Stock Exchange under the symbol EDT, and on the OTCQX under the symbol EDTXF. For more information, please visit Spectral Medical Inc. The first theranostic approach to Sepsis.
Forward-looking statements
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 commercialize its products, the ability of Spectral to take advantage of business opportunities in the biomedical industry, the granting of necessary approvals by regulatory authorities, the ability of Spectral to complete the Offering as expected 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.
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  #98  
Old 06-02-2016, 12:25 PM
Bozzie Bozzie is offline
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This company has a history of delivering on PR.
I was thinking about them highlighting the Continued use program in this weeks announcement.
IMO you wouldn't PR Continued use (Compassionate use) unless you had a very good idea you would be approved, if the status was denied it would be looked at as a total failure...The SP would slip and the trail success would be put in question altogether by investors, Just knowing these guys as a company and the ultra conservative history in the PR department it seems to me we should get confirmation that the program has started in June sometime.
In my mind, when Spectral announces official approval of compassionate access program, it's game over we win. Any grizzled pharmaceutical executive will know at that point, that complete and total FDA approval of PMX is a foregone conclusion. That's when serious partnership/buyout offers will be made because that is when big pharma will know for sure that PMX is definitely going to be commercialized in North America.

Love, Bozzie
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  #99  
Old 06-07-2016, 02:16 AM
Bozzie Bozzie is offline
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Decent read

What are septic shock and sepsis? - Business Insider
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  #100  
Old 06-08-2016, 04:02 AM
tigerman19 tigerman19 is online now
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Was about to post that also. Hate there was no mention of spectral and where they are with the fda in the article.
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