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  #101  
Old 06-12-2016, 07:16 PM
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I don't get it at all. 2 Fridays in a row with really low volume and the stock takes a big dip from a trade just before closing time? Any ideas?
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  #102  
Old 06-13-2016, 01:13 AM
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Nope.No idea.
I will say there should be an announcement in the next few weeks regarding the end of the trial and hopefully enterery into the continued use program... September is when results should be posted by the DSMB .. it's going to be small steps here for a bit but progressively we should see a price jump too.I know you have made money but this is when its going to take nuts to stay in, it's all up to the FDA at some point buddy.. hang in there. It's not easy for me either but i have faith this is going to be approved.

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  #103  
Old 06-13-2016, 12:40 PM
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My cost per share is $.56 so got good bit of wiggle room. It's just confusing to me. I'd like buy and sell but I'm sure I'd fuck that up so I'm just gonna continue riding it out. Perhaps keep adding 1000 here/1000 there.
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  #104  
Old 06-13-2016, 01:16 PM
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i don't think there is the liquidity to trade right now and things are too unpredictable day to day as you said the sell offs come out of nowhere...
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  #105  
Old 06-13-2016, 06:16 PM
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Originally Posted by tigerman19 View Post
I don't get it at all. 2 Fridays in a row with really low volume and the stock takes a big dip from a trade just before closing time? Any ideas?
it happen again today, my buddies thinking below.

2 minutes to go and somebody slams all the bids down 4 cents and then offers a ton of stock (86k) for the last 2 minutes of the day. Then 10 minutes after the close they cancel the offer during after hours trading. It's so weird. I can't figure out why somebody would do that. It's like they want the market to know that they still have stock to sell.
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  #106  
Old 06-16-2016, 11:45 AM
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Spectral Medical Inc.
June 16, 2016 08:00 ET

Spectral Medical Announces Acceptance of Pre-Clinical PMA Module for Toraymyxin™ by FDA
Company remains on track and anticipates final submission in Q4 2016
FDA accepts Spectral's 510(k) filing for its standalone pump for review
TORONTO, ONTARIO--(Marketwired - June 16, 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 the U.S. Food and Drug Administration (FDA) has reviewed and accepted one of the two pre-clinical modules in its PMA application for Toraymyxin™, the Company's investigational therapeutic hemoperfusion device that removes endotoxin from the bloodstream. With acceptance of this module the Company remains on track to complete its full PMA submission by the end of 2016.
"As we look toward completing our submission to the FDA this year, the Agency's acceptance of this module is a significant milestone," said Dr. Paul Walker, President and CEO of Spectral. "This particular section contains key pre-clinical data on the use of Toraymyxin™ for patients with septic shock, including the device's engineering and bench testing; sterilization and shelf life; packaging and transport details. We are encouraged that the FDA accepted this data, which is critical to our submission, as we continue to advance our regulatory filing with the goal of bringing this treatment to people in need."
A novel therapy for certain patients in septic shock, Toraymyxin™ is specifically targeted at those with elevated levels of endotoxin in the blood. Toraymyxin™ is a direct hemoperfusion adsorption column that has been shown to be highly effective in removing endotoxin. Studies have shown that this medical device can remove up to 90 percent of an endotoxemic patient's circulating endotoxin when administered twice within a 24 hour period.
As part of the modular PMA filing, Spectral will submit a total of four modules of documentation for review in stages by the FDA. Two of the modules include pre- clinical information, one describes the manufacturing process and the last module contains clinical data. Three modules have been submitted and one of the pre- clinical modules has now been fully reviewed and accepted. Spectral plans to submit its fourth and final module, comprising data from its pivotal EUPHRATES trial, by the end of 2016.
In related news, Spectral announced that the FDA has also accepted for review the Company's separate 510(k) filing for a standalone pump that could facilitate treatment delivery in the Intensive Care Unit (ICU) and increase options available to clinicians.
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  #107  
Old 06-16-2016, 11:48 AM
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Top line results in September, that will be the point this has wings or not.
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  #108  
Old 06-20-2016, 10:26 AM
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Trial is finally done.
One thing i've learned from watching this company and a few others go through the possess of approval with the FDA is that the market moves mostly when the FDA gives positive feed back. I would expect the FDA to grant continued use any day now and hopefully that will give us a small price jump and put this on a few peoples radar.

I'm not sure who reads this and information is available at other sources but i will continue to update up to completion.

Spectral Medical Announces Completion of Enrolment for Its Pivotal EUPHRATES Clinical Trial
Company expects to announce primary clinical outcome results by end of September
Final module of PMA submission anticipated in Q4 2016
TORONTO, ONTARIO--(Marketwired - June 20, 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 due to endotoxemia, today announced that patient enrollment has been completed for the Company's pivotal Phase III EUPHRATES clinical trial.
The clinical trial is intended to demonstrate the safety and efficacy of Toraymyxin™, an investigational device that removes endotoxin from the bloodstream. Over 900 patients who met clinical entry criteria for septic shock were evaluated using the Company's proprietary Endotoxin Activity Assay, which measures the level of endotoxin in the bloodstream. This lead to a total of 446 evaluable patients who were enrolled and randomized into the trial at 42 hospitals in the United States and Canada. The primary endpoint of the trial is a reduction in 28 day mortality in patients treated with Toraymyxin™.
"The EUPHRATES trial is a randomized, prospective, blinded trial evaluating a novel approach to the treatment of septic shock, combining a targeted diagnostic and therapeutic. This protocol required tremendous dedication and hard work from clinical research staff at each of the hospitals," stated Debra Foster, VP Clinical Development for Spectral. "We also thank the many patients and their loved ones who consented to be part of this trial."
"The completion of patient enrollment in the EUPHRATES trial is an important step in our mission to commercialize a treatment that addresses an enormous unmet medical need," said Dr. Paul Walker, President and CEO of Spectral. "Over the coming months, we will collect and analyze all required data with the expectation of announcing primary outcome results in September. We remain fully on-track to complete our PMA application with the FDA by year's end."
A novel therapy for certain patients in septic shock, Toraymyxin™ is specifically targeted at those with elevated levels of endotoxin in the blood. Toraymyxin™ is a direct hemoperfusion adsorption column that has been shown to be highly effective in removing endotoxin. Studies have shown that this medical device can remove up to 90 percent of an endotoxemic patient's circulating endotoxin when administered twice within a 24 hour period.
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Last edited by Bozzie; 06-20-2016 at 10:28 AM.
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  #109  
Old 06-25-2016, 12:47 PM
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Thanks for the updates bud.
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  #110  
Old 06-27-2016, 08:29 AM
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woot woot.. expanded use accepted by the FDA.
Great news and a big step toward approval...a true confirmation the trail has decent numbers.



FDA Accepts Spectral's Expanded Access Protocol for Toraymyxin™
Toraymyxin™ may now be used at hospitals that participated in EUPHRATES trial
TORONTO, ONTARIO--(Marketwired - June 27, 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 endotoxemic septic shock, today announced that the U.S. Food and Drug Administration (FDA) has accepted its protocol for Expanded Access of Toraymyxin™, the Company's investigational therapeutic device that removes endotoxin from the bloodstream.
The Expanded Access program, sometimes referred to as Compassionate Use, can now begin at certain of the 29 U.S. hospitals that had participated in the recently completed Phase III EUPHRATES clinical trial and have agreed to be part of this program. 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 were 12 hospitals engaged in the clinical trial.
"As we move to complete our PMA submission for Toraymyxin™ with the FDA later this year, physicians in our clinical trial locations can now have immediate access to a therapy that has been used on more than 150,000 patients outside of North America for more than a decade," said Dr. Paul Walker, President and CEO of Spectral. "Prior clinical research has demonstrated that removing endotoxin from the blood with Toraymyxin™ can result in positive patient outcomes and a reduction in mortality."
A novel therapy for certain patients in septic shock, Toraymyxin™ is a medical device specifically targeted at those with elevated levels of endotoxin in the blood. Toraymyxin™ is a direct hemoperfusion adsorption column that has been shown to be highly effective in removing endotoxin. Studies have shown that Toraymyxin™ can remove up to 90 percent of an endotoxemic patient's circulating endotoxin when administered twice within a 24 hour period.
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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  #111  
Old 06-28-2016, 07:43 PM
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Great interview.

https://twitter.com/MassDevice/statu...81978716889088
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  #112  
Old 06-29-2016, 12:47 PM
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Originally Posted by Bozzie View Post
Loved the end of this where he talks about a potential buyout as well as other potential applications for the device. Didn't love the part about raising more money.
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  #113  
Old 07-04-2016, 07:26 PM
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Happy 4th !!!!


Spectral Announces Normal Course Issuer Bid
T.EDT | 12 hours ago
TORONTO, ONTARIO--(Marketwired - July 4, 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 the Toronto Stock Exchange ("TSX") has accepted Spectral's notice of intention to proceed with a normal course issuer bid through the facilities of the TSX.

Pursuant to the notice, Spectral may purchase up to 4,134,664 of its common shares ("Shares"), representing approximately 2% of its issued and outstanding Shares, during the twelve month period commencing July 6, 2016 and ending July 5, 2017. As of June 27, 2016, there were 206,733,209 Shares issued and outstanding. Under the normal course issuer bid, Spectral may purchase up to 25,757 Shares on the TSX during any trading day, which represents approximately 25% of the average daily trading volume on the TSX, which is 103,028 Shares for the most recently completed six calendar months as of May 31, 2016. This limitation does not apply to purchases made pursuant to block purchase exemptions. Purchases will be executed through the facilities of the TSX at market prices under the normal course issuer bid rules of the TSX. Any Shares purchased under the normal course issuer bid will be cancelled.

Although Spectral intends to purchase Shares under its normal course issuer bid, there can be no assurances that any such purchases will be completed. Such purchases, if any, may commence on July 6, 2016 and will terminate on July 5, 2017, or on such earlier date as Spectral may complete its purchases pursuant to the notice of intention filed today with the TSX or provide notice of termination. Any such purchases will be made by Spectral at the prevailing market price at the time of acquisition and through the facilities of the TSX.

Spectral commenced a normal course issuer bid on December 17, 2014 that ended on December 16, 2015. Under such normal course issuer bid, Spectral purchased 480,000 Shares and the weighted average price paid per Share was $0.7396.

Spectral believes that the Shares have been trading in a price range which does not adequately reflect their value in relation to the business of Spectral and its future business prospects. As a result, depending upon future trading prices of the Shares and other factors, Spectral believes that the Shares may represent an attractive investment to Spectral. Furthermore, any purchases made under the normal course issuer bid can be expected to benefit all persons who continue to hold Shares by increasing their percentage equity interest in Spectral.


Read more at Spectral Announces Normal Course Issuer Bid
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  #114  
Old 07-04-2016, 08:07 PM
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Most buy backs are great as long as it is done without the intention of cutting into R&D. There is a reason the company wanted to raise capitol in the first place...but encouraging news

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  #115  
Old 07-05-2016, 10:04 AM
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Yeah, seems odd that they think they'll have the cash to complete buy backs in the next 12 months. More of a statement on the share price vs. intrinsic value?
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  #116  
Old 07-05-2016, 12:31 PM
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Sure sign they are not going to commercialize this.
I like it, feels like the blindfold has been removed.
Someone just put up 170K at 1.04 then dropped it to 1.01.
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  #117  
Old 07-05-2016, 07:17 PM
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Another 3:59 daily low trade. Transparent manipulation, but who/why?
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  #118  
Old 07-06-2016, 10:36 AM
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I have no idea cap, very strange but i will say if top line results are good in September whoever it is will be buried in the volume wave, i don't think it matters day to day but it is strange. Whoever put up the 170K yesterday didn't care that the stock had upward momentum, looks like buyers bit off 90k of the 170K so today a suspect we will see downward movement till the seller is done hopefully today.
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  #119  
Old 07-06-2016, 10:50 AM
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July IR, lots of new slides confirming the 20% absolute mortality reduction.

http://www.spectraldx.com/assets/spe...pdate_0616.pdf

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  #120  
Old 07-06-2016, 04:57 PM
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The thing that I can't understand about these late day trades is the volume associated with them. Maybe it's because I don't know the Canadian movement? But I see a volume of 23,800. Several early trades, looks like the 5000 and 10,000 type, result in $.01 and $.02 moves up then a 3:55 trade at only couple thousand shares results in a $.06 drop. That's the wtf for me.
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  #121  
Old 07-07-2016, 01:12 AM
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Often it is the specialist because it lowers cost of his position, not uncommon.
Late in the day and small amounts makes sense because he is the market and wants a lower his base over night so he just sells enough for a buyer to lift him tomorrow.
It's tough to watch the price move but in the end it is all about approval.

The good thing is the mortality numbers on the July IR look very promising.
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Last edited by Bozzie; 07-07-2016 at 01:15 AM.
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  #122  
Old 07-09-2016, 03:25 AM
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Hit a 3:55 trade today. Lol.
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  #123  
Old 07-13-2016, 11:04 AM
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nice little write up.

Canada's Spectral hoping to win U.S. approval for sepsis treatment | Reuters
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  #124  
Old 07-15-2016, 05:34 PM
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Guess we all knew that was gonna happen.
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  #125  
Old 07-16-2016, 02:01 PM
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I thinking this may break through the 52 week high next week.
The big seller seems to have evaporated.
Loving the numbers presented in the July IR.
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