Go Back   Sports Handicapping at cappersmall > > >

Notices

Stocks Discuss stock trading, tips & the market

Reply
 
Thread Tools Display Modes
  #26  
Old 04-11-2015, 11:15 PM
Bozzie Bozzie is offline
Sweet action
 
Join Date: Sep 2005
Posts: 6,876
Rewards: 1,215
Post Thanks / Like
Likes (Given): 606
Likes (Received): 701
Tailor made for this little gem…

FDA launches Expedited Access Pathway program for devices
April 10, 2015
The FDA has introduced its Expedited Access Pathway Program, a voluntary program designed to reduce the time from development to marketing decision for certain lifesaving medical devices, the agency said on its website.
Under the program, sponsors of devices to treat life-threatening or debilitating conditions that address an unmet need can request an Expedited Access Pathway (EAP) designation. The FDA’s Center for Devices and Radiological Health (CDRH) will work with developers of these devices to decrease the time and cost to bring these devices to the market. The CDRH will collaborate with device manufacturers to establish a Data Development Plan, which will transfer premarket data collection to the postmarket setting, where appropriate, while still meeting the FDA’s approval standard of reasonable assurance of safety and effectiveness.
“Under the EAP, FDA may accept a greater degree of uncertainty if it is sufficiently balanced by other factors, including the probable benefits to having earlier access to the device,” Jeffrey Shuren, MD, director of the CDRH, wrote in a blog post. “If, after careful analysis, FDA determines that some data can be collected after the device is on the market, patients in need will benefit sooner.”
This decision may be influenced by factors such as low likelihood of serious harm from the device, high probability that instances of serious patient harm will be quickly identified in postmarket surveillance, and high probability that postmarket data collection will be completed expeditiously.
The FDA will begin to consider requests for EAP designation starting April 15.
A device may be eligible for an EAP designation if it is designed for the treatment or diagnosis of a life-threatening or permanently disabling condition.
__________________
peace

Last edited by Bozzie; 04-11-2015 at 11:17 PM.
Reply With Quote
  #27  
Old 07-17-2015, 09:54 AM
Bozzie Bozzie is offline
Sweet action
 
Join Date: Sep 2005
Posts: 6,876
Rewards: 1,215
Post Thanks / Like
Likes (Given): 606
Likes (Received): 701
July IR from the company web site.
This is coming down to the wire... approval or failure is within sight.
Things are looking very positive at this point.

Bullet points:

360 patients randomized as of July 8, 2015 (90 since April, 2014 additional exclusion criterion that further refined patient selection)

42 hospitals participating in trial (32 in U.S. and 10 in Canada)

Current trend (50%+ composite mortality) suggests a strong clinical signal in the same range as the EUPHAS study and a much smaller sample size than previously anticipated to achieve statistically significant outcome

Spectral has started rolling Pre Market Approval (PMA) submission as agreed with FDA

Interim analysis at 90+ patients was recommended by DSMB. Analysis and sample size recalculation planned for Q3 of this year

Probability of commercialization in 2016 is increasing
The Clinical/Regulatory Pathway
__________________
Likes Steel liked this post
peace

Last edited by Bozzie; 07-17-2015 at 10:34 AM.
Reply With Quote
  #28  
Old 07-17-2015, 04:18 PM
Steel Steel is offline
Registered User
 
Join Date: Dec 2004
Posts: 23,782
Rewards: 20,971
Post Thanks / Like
Likes (Given): 3674
Likes (Received): 1837
Bozzie, is this stock worth buying at .81 ?
__________________
Likes Bozzie liked this post
Reply With Quote
  #29  
Old 07-17-2015, 07:58 PM
Bozzie Bozzie is offline
Sweet action
 
Join Date: Sep 2005
Posts: 6,876
Rewards: 1,215
Post Thanks / Like
Likes (Given): 606
Likes (Received): 701
Hey buddy

It is...I expect FDA approval soon perhaps within this year.
It's is a pink sheet stock in the US trading on the OTC market so there is high risk.
Today it was 81 cents Canadian/ call letters EDT.TO on the Toronto market.
Or 64 cents on the US OTC market/ call letters EDTXF
There is a 5 day settling period for newly funded accounts.. Meaning your money will sit for 5 biz days before you can buy on the OTC.. think its a FTC rule actually.
Its a super small Canadian company 21 employees with a CEO who prefers flying under the radar with an approval this could be a +20 bagger
I'm in deep. too deep I own around 300k Shares and this is most likely the biggest gamble of my life.I have done a huge amount of DD on this over the years and follow company details daily.
Sepsis is a riddle phama has been trying to solve for many years with many failed trials late in development.
This could be good or horrible depending on the FDA.


This is a post from the stockhouse board i read about this stock this guy has a good idea of what is happening... meaning he is correct about the shots for FDA approval.


gammagrouch wrote: Unfortunately our board has been invaded by an incessant talker with multiple aliases (mm/swyg). Those of you that are new would do well to put both of their handles on ignore. The person behind these handles is clueless and because he lacks brain power, he is forced to go on wild tangents that are totally irrelevant. He spends way too much time writing gibberish, when instead he could be using that time to think things through. Just look at all those useless post, it's no wonder that he's so confused. He's so desperate for somebody to spoon feed him the knowledge that he himself should have figured out on his own.

What Porkchop Boy is failing to grasp is that statistical proof is immensely more valuable than an EAP. Statistical proof gets you into every ICU in North America within a very short time frame. EAP is nice but it was not designed for a late stage phase 3 trial that is on the cusp of proving something amazing. That's not to say that EAP isn't a possible pathway that is being simultaneously worked on, but statistical proof is goal number one. And EAP is therefore a close second.

Spectral Medical is the focal point of an incredible amount of effort, by many great scientist across the world, to prove the endotoxin removal postulate. From all the hard work that was put into EUPHAS 1 and EUPHAS 2, to the tremendous efforts put in by Iwagami et al, and Cruz et al, and even all the way back to 1949 when a Japanese researcher first discovered Polymyxin E (Colistin) in a flask of fermenting bacteria. Spectral Medical and their EUPHRATES trial is the culmination of all these great efforts. The culmination of an insane amount of research and data gathering. I doubt any of us will ever see another phase 3 trial that is the product of so much effort, from scientist all across the globe, and from different eras.

Once you understand the legacy that is behind EUPHRATES, you will see that there really is only one question that you should be asking yourself; What happens to the EUPHRATES trial if Spectral gets an EAP designation?

To be more specific, does an EAP designation create an ethical dilemma in regards to the placebo group? In other words, if a treatment is available via EAP, then how can you ethically deny patients in the trial access to it?

It's a very big question but once you've reflected on it for good amount of time, you will then start to see why things are unfolding the way they are. Spectral has 2 clean shots on goal. One is achieving statistical proof, which in my opinion could happen in the 90-110 patient range. And the other is an EAP designation. It's nice having 2 clean shots, most companies are lucky if they ever get one. If our first shot wins the game, then there is no need to take the second shot. Making the first shot would definitely be magnificent, but as an investor, it's nice to know that we will get a second one if needed. Best of luck to all of you true shareholders.

Note: the company just reached the 90 patient mark and todays IR makes me think the results are being calculated by the DSMB (the arm of the FDA who reads trial data) then makes recommendations to the FDA.

Could be news anytime.


July IR

http://www.spectraldx.com/assets/spe...r-july2015.pdf

Read more at Spectral Medical Inc ( T.EDT ) stock message board and forum - Bullboard Discussion - Stockhouse Community
__________________
peace

Last edited by Bozzie; 07-17-2015 at 08:16 PM.
Reply With Quote
  #30  
Old 07-17-2015, 10:23 PM
Steel Steel is offline
Registered User
 
Join Date: Dec 2004
Posts: 23,782
Rewards: 20,971
Post Thanks / Like
Likes (Given): 3674
Likes (Received): 1837
Thanks Bozzie
Reply With Quote
  #31  
Old 07-28-2015, 05:56 PM
Bozzie Bozzie is offline
Sweet action
 
Join Date: Sep 2005
Posts: 6,876
Rewards: 1,215
Post Thanks / Like
Likes (Given): 606
Likes (Received): 701
This is a decent timeline of recent developments from a recent post on stockhouse.

.................................................. .................................................. .............................................

Spectral needs to hit a home run on data...
....and THEY think they will. Do you?

In a clinical update press release on March 11, 2014 Spectral advised:

"The EUPHRATES trial was designed to show a benefit in mortality between the treated group and the control group of between 10% to 15% at a power of eighty percent. The original sample size of 360 enrolled patients would be required to show a 15% benefit in mortality, while demonstrating a 10% difference could require up to approximately 700 patients."

On April 14, 2014 the Spectral press release stated:

"Based on the current recommendations of the DSMB, the sample size has been recalculated and increased from 360 to 650 patients."

There was no mention of the exact mortality benefit, but based on the sample size increase (360 to 650) it appears the first 271 enrolled had a mortality benefit slightly better than 10%.

By my math, it looks like they need to arrive at an unreal 28% mortality benefit (on the last 90 enrolled) in order to arrive at a 15% mortality benefit for 360 enrolled thus far (I'm giving the first 271 enrolled a 10.5% mortality benefit).

I think they can do it, and I'll argue Spectral already knows they can.

Spectral is blinded outside the composite mortality rates and the total # of patients enrolled. They've advised the EUPHRATES mortality rates are trending similarly to EUPHAS (50%). Spectral is blinded to the mortality rates of the individual arms. But what if they had a good idea on one of the arms??? Then it's basic math to figure out the other arm by adding or subtracting the composite rate. Right? My theory is that they have a real good idea that the mortality rate is around 30-35% for the Toraymyxin column arm. They have Japan's and Europe's trial numbers to support this, and come out and say it on page 12 of the July 2015 Investor Presentation.

"PMX saves the lives of 1 in 3 patients with septic shock and high endotoxin."

****(anybody notice it was 1 in 4 patients in the May 2015 presentation???)***

The DSMB recommended 90+. On May 12, 2015, they had 82 enrolled, 88 on June 15, and 90 on July 8. To me it looks like they chose to stop enrolling @ 90 because they are confident the trial will be stopped. If it was borderline, you would think they would/should keep enrolling as every patient gets them closer to obtaining a better statistical power and chance to succeed. Maybe they are still enrolling?

The placebo # is the big mystery. Napodano thinks placebo is 60%. I think it's higher based on the new agreed enrollment criterion. Sicker patients being selected, but not too sick. There are only 45 patients in the placebo since last analysis. The small patient count is what makes it anybody's guess.

If we believe the Toraymyxin column arm mortality rate is at 35% (like it appears Spectral does), and we KNOW the composite rate is at 50%, then we can surmise the placebo arm is at 65%. This = a 30% home run mortality benefit.

If this is true, my heart goes out to the placebo group's friends and family that lost their loved ones knowing they might have had a 30% better chance at living if they were given the Toraymyxin column.

Spectral has updated their website each month after the news release in May, 2015. Is the update in August going to be a basic enrollment update, or a full blown press release of trial data? Are we getting up to date #'s for the first time since 4/14/14???

Hopefully we have good news and the DSMB recommends trial stoppage so we can have some fun trying to come up with a valuation until a possible FDA approval. Until then, good luck to all that have a lot at stake like I do. I've been buying for the past two years (as high as .88 and low as .23 US). Cheers.

Batsky

Spectral Medical Inc ( EDTXF ) stock message board and forum - Bullboard Discussion - Stockhouse Community
__________________
Likes Roma liked this post
peace
Reply With Quote
  #32  
Old 08-13-2015, 11:24 AM
Bozzie Bozzie is offline
Sweet action
 
Join Date: Sep 2005
Posts: 6,876
Rewards: 1,215
Post Thanks / Like
Likes (Given): 606
Likes (Received): 701
I'm still full on here.
Funded today to buy another 10,000 on the american market.
Loving the recent dip.
I'm feeling very bullish.

Love Bozzie
__________________
peace
Reply With Quote
  #33  
Old 09-14-2015, 10:57 AM
Bozzie Bozzie is offline
Sweet action
 
Join Date: Sep 2005
Posts: 6,876
Rewards: 1,215
Post Thanks / Like
Likes (Given): 606
Likes (Received): 701
Looks like we have a completion date.
All postive.
Mid 2016.

Spectral Now Recruiting the Last 75 Patients in Its Phase III Trial
On Track to File for FDA Market Approval in 2016
TORONTO, ONTARIO--(Marketwired - Sept. 14, 2015) - Spectral Medical Inc. ("Spectral" or the "Company"), (TSX:EDT)(OTCQX:EDTXF), a Phase III company developing the first treatment for patients with septic shock that comprises a therapeutic device guided by a companion diagnostic, today announced that it is now recruiting the last 75 patients into its pivotal Phase III EUPHRATES clinical trial under a revised statistical plan accepted by the US Food and Drug Administration ("FDA"). Based on current enrolment rates, it is expected that the trial should be completed by mid-2016.
The Company further announces that it is on track with submitting its Pre-Market Approval ("PMA") modules, having already filed two of the four required modules, and that it expects to file its last module with the EUPHRATES clinical data in Q4 2016 for market approval of its Toraymyxin™ ("PMX") medical device.
"I am very pleased and excited about the significant progress we have made towards our goal of solving a large unmet medical need in the area of sepsis, a condition which kills over 300,000 people in North America each year," said Dr. Paul Walker, CEO and President of Spectral Medical. "Our regulatory, clinical and commercialization programs are all coming together and have positioned us well for a potential 2017 launch into an estimated $3 billion market opportunity, for which there are currently no approved therapies."
Clinical Progress
As of today's date, 371 patients (101 since the April 10, 2014 protocol change to implement an additional exclusion criterion) have been randomized into the EUPHRATES trial and an average of eight new patients per month have been enrolled during the 2015 calendar year, after adjusting for the typically slower summer months.
The composite mortality rate of randomized patients in the trial since the protocol change has increased significantly and is now, on average, approximately 50 percent, which trend prompted the Data Safety Monitoring Board ("DSMB") to recommend that the Company consider another interim analysis in order to recalculate the appropriate sample size for this specific patient population. By comparison, the composite mortality rate at the time of the planned interim analysis, conducted in January 2014, was approximately 30 percent.
After consulting with regulatory advisors, independent statisticians and the trial's Steering Committee, the Company elected to revise the sample size for its EUPHRATES trial using a scientifically valid methodology other than a traditional interim analysis with stopping rules for safety, efficacy or futility. This approach has been supported by the trial's Steering Committee and is considered to be more reliable for purposes of a sample size recalculation than using numbers derived only from an analysis based on a relatively small randomized patient population.
Statistical analysis was performed based on the actual composite mortality rate of patients randomized in the trial (approximately 50 percent) and the actual mortality rate of similar patients who were treated with the PMX medical device in Europe using the same protocol as the EUPHRATES trial (approximately 40 percent). The mortality data for these treated patients was drawn from a validated patient registry which has been tracking such information for over three years. The sample size recalculation is further supported by independent published data showing a predicted mortality rate in the range of 60 to 65 percent for patients in septic shock with a multiple organ dysfunction score ("MODS") similar to those being randomized in our trial.
The sample size has now been set at 446 evaluable patients (previously 650), of which 176 patients randomized after the protocol change will be considered for determination of the primary end point of 28-day mortality, as recommended by the FDA. The trial remains powered at 80 percent and the alpha remains at < 0.05 for its primary end point. The methodology for the sample size recalculation was presented to the DSMB at its quarterly meeting on September 3, 2015 and was accepted without further comment or the need for an interim analysis for this purpose, as had been previously contemplated. The Company submitted its revised statistical analysis plan to the FDA and it was accepted.
The Company is now on track to recruit the last 75 of the required 446 evaluable trial patients. Based on current enrolment rates, it is expected that the trial should be completed by mid-2016.
Regulatory Progress
Following a series of meetings, Spectral and the FDA have concluded that, based on progress made to date, the most effective and fastest pathway for the Company to obtain market approval is by continuing to move forward with the EUPHRATES trial and implementing the rolling PMA submission plan that has already been accepted by the FDA.
The first of four separate PMA modules was submitted to the FDA in June 2015 and the second module was submitted earlier this month. The third module is expected to be filed early in the fourth quarter of 2015 in accordance with timeframes previously established with the FDA. The final module, consisting of clinical data, will be submitted when the Company determines that cumulative data from the EUPHRATES trial and other sources is sufficient for this purpose. This is targeted to occur in the fourth quarter of 2016 as a final step towards anticipated FDA approval.
Commercialization Progress
The Company has taken a number of other operational and strategic measures to prepare itself for commercialization.
These measures include the development of a proprietary stand-alone pump dedicated to our therapy that enables treatment delivery in the Intensive Care Unit ("ICU") and reduces reliance on third party instrumentation. The addition of this state of the art equipment will enable the Company to provide a fully integrated and user friendly septic shock treatment system to the ICU. The stand-alone pump is also designed to provide an open platform for other hemoperfusion cartridges and to deliver continuous renal replacement therapy ("CRRT") when indicated. Approval of this instrument by Health Canada is anticipated during the fourth quarter of 2015, with 510K approval in the United States targeted for the first quarter of 2016.
Other commercialization initiatives include new packaging for the EAA™ (Endotoxin Activity Assay) diagnostic to simplify usage and reduce lab technician time in hospitals; the automation and scale up of the manufacturing process at Spectral's plant in Toronto, Canada to increase production capacity; and lastly, the Company is planning for a sales and distribution infrastructure capable of servicing a large potential market in anticipation of timely FDA approval and subsequent commercialization of its unique treatment for septic shock.
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. PMX is a therapeutic hemoperfusion device that removes endotoxin, a main trigger of sepsis, 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 100,000 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..
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 take advantage of business opportunities in the biomedical industry, the granting of necessary approvals by regulatory authorities 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.
__________________
Likes hodge333 liked this post
peace
Reply With Quote
  #34  
Old 10-02-2015, 09:29 PM
jim1701 jim1701 is offline
Da KEYper!!
 
Join Date: Apr 2007
Location: back in gud ole Tennessee
Posts: 2,765
Rewards: 9,258
Post Thanks / Like
Likes (Given): 10
Likes (Received): 18
U da man Bozz....great work Im praying for you this hits well!! You remind me of da old days back in 06-07 when id check this link...w00t!
__________________
Likes Bozzie liked this post
Free Survivor 2016
Reply With Quote
  #35  
Old 10-09-2015, 10:04 AM
Bozzie Bozzie is offline
Sweet action
 
Join Date: Sep 2005
Posts: 6,876
Rewards: 1,215
Post Thanks / Like
Likes (Given): 606
Likes (Received): 701
Quote:
Originally Posted by jim1701 View Post
U da man Bozz....great work Im praying for you this hits well!! You remind me of da old days back in 06-07 when id check this link...w00t!
Right on Jim, Thanks
It's been a long road, the FDA is tough and unpredictable.
Something tells me this timeline may be a bit off.
The device is getting high efficiency numbers with the most critically ill segment of the population the FDA can't hold back on this for much longer.

I will keep the updates coming.

Love Bozzie
__________________
peace
Reply With Quote
  #36  
Old 10-28-2015, 10:21 PM
Carlito Brigante Carlito Brigante is offline
C'mon Man!
 
Join Date: Oct 2010
Posts: 3,902
Rewards: 64,899
Post Thanks / Like
Likes (Given): 3414
Likes (Received): 3948
Thanks for the updates Bozzie.
Reply With Quote
  #37  
Old 01-12-2016, 11:27 AM
Bozzie Bozzie is offline
Sweet action
 
Join Date: Sep 2005
Posts: 6,876
Rewards: 1,215
Post Thanks / Like
Likes (Given): 606
Likes (Received): 701
46 more subjects to enroll in the FDA study, estimated time of completion is June.
Today Mackie research put a speculative buy rating today at 2.50 Canadian
Also the FDA OKed this for compassionate use after the last 46 subjects are processed, something the FDA is not in the habit of doing unless things are very positive.

A lot of signs are looking good.
__________________
peace
Reply With Quote
  #38  
Old 02-02-2016, 11:32 AM
Bozzie Bozzie is offline
Sweet action
 
Join Date: Sep 2005
Posts: 6,876
Rewards: 1,215
Post Thanks / Like
Likes (Given): 606
Likes (Received): 701
Financed for 10 million to finish the trial ,this will be the last of the financing.
Things must be looking positive to receive a chunk of money in a "Bought Deal" this late in the 3rd phase.

I just keep adding

Spectral Medical Inc. Announces $10,010,000 Bought Deal Financing

Positive news from the field

http://erlangernow.org/erlanger-a-to...linical-trial/
__________________
peace

Last edited by Bozzie; 02-02-2016 at 11:39 AM.
Reply With Quote
  #39  
Old 02-03-2016, 12:31 AM
nutty_bar nutty_bar is offline
Registered User
 
Join Date: Aug 2010
Posts: 220
Rewards: 1,463
Post Thanks / Like
Likes (Given): 1
Likes (Received): 49
Hi bozzie, I see you very optimistic with this. But my question is, wouldn't everyone jump on this stock already, anticipating the same thing you are?
I feel that the public,like us, is always fooled... If this opportunity is as good as you have been saying, this stock would already attract interest from insiders. Just my thought, thread with caution my friend.

Nutty
Reply With Quote
  #40  
Old 02-03-2016, 09:38 PM
Bozzie Bozzie is offline
Sweet action
 
Join Date: Sep 2005
Posts: 6,876
Rewards: 1,215
Post Thanks / Like
Likes (Given): 606
Likes (Received): 701
Quote:
Originally Posted by nutty_bar View Post
Hi bozzie, I see you very optimistic with this. But my question is, wouldn't everyone jump on this stock already, anticipating the same thing you are?
I feel that the public,like us, is always fooled... If this opportunity is as good as you have been saying, this stock would already attract interest from insiders. Just my thought, thread with caution my friend.

Nutty

Thanks for the word.
Yes, but not always this is very lightly promoted and trading on a Canadian exchange.
The fact this is for sepsis sends off warning signs to most savvy bio investors.
It's 80% insider held at this point, Like i've always said this is a long shot.

GL nutty
__________________
peace
Reply With Quote
  #41  
Old 02-04-2016, 09:57 AM
capainter capainter is online now
Registered User
 
Join Date: Sep 2008
Posts: 995
Rewards: 36,563
Post Thanks / Like
Likes (Given): 143
Likes (Received): 155
Bozzie,

Thanks for the heads up on this. I just noticed this post several weeks ago and have been tracking since. There hasn't been much movement in the stock price. I was waiting for a little dip but it's so lightly traded that it didn't move even during the first two weeks of January. I'll probably snap up some shares at some point.

Just an FYI, the July '15 presentation says its 45% owned by insiders, not 80%. Probably slightly less at this point with the last issuance. But whatever.

My question is this - any idea what made it spike from 20-some cents all the way to almost $1 early last year? Just optimism that the trial would be over soon?
Reply With Quote
  #42  
Old 02-04-2016, 11:22 AM
Bozzie Bozzie is offline
Sweet action
 
Join Date: Sep 2005
Posts: 6,876
Rewards: 1,215
Post Thanks / Like
Likes (Given): 606
Likes (Received): 701
Hey Capainter

You're right it is 45% insider..I was thinking institutional holdings at 70% with a 30 % retail float sorry about that Cap.
The move last year was after a favorable DSMB meeting. DSMB is the board who collects and analyzes data for the FDA.

We are getting near the end..One new bit of info in the January investor presentation that is the DSMB/FDA agreeing to compassionate use after the final 46 are entered into the trial sometime in the 3rd quarter of this year.
__________________
peace
Reply With Quote
  #43  
Old 02-13-2016, 05:26 PM
Bozzie Bozzie is offline
Sweet action
 
Join Date: Sep 2005
Posts: 6,876
Rewards: 1,215
Post Thanks / Like
Likes (Given): 606
Likes (Received): 701
Good sign....Long time director Mr. Herrera has exercised 200K options this week. So far he has not sold any shares. Given the options all carried different expiry dates, it is nice to see he was willing to buy or cash in coupons that he was not forced to exercise.
__________________
peace
Reply With Quote
  #44  
Old 02-18-2016, 10:09 AM
Bozzie Bozzie is offline
Sweet action
 
Join Date: Sep 2005
Posts: 6,876
Rewards: 1,215
Post Thanks / Like
Likes (Given): 606
Likes (Received): 701
Birch Hill subscribed to 533,000 shares of the offering today calculated on a non-diluted basis , Birch hill is the second largest holder, another very strong sign that things are on track. hopefully this moves higher now that the bought deal is complete.
Link:
Stockwatch
__________________
peace
Reply With Quote
  #45  
Old 02-18-2016, 01:53 PM
nutty_bar nutty_bar is offline
Registered User
 
Join Date: Aug 2010
Posts: 220
Rewards: 1,463
Post Thanks / Like
Likes (Given): 1
Likes (Received): 49
Hey bozzie, what would be your target with this stock?
Reply With Quote
  #46  
Old 02-18-2016, 03:20 PM
Bozzie Bozzie is offline
Sweet action
 
Join Date: Sep 2005
Posts: 6,876
Rewards: 1,215
Post Thanks / Like
Likes (Given): 606
Likes (Received): 701
Quote:
Originally Posted by nutty_bar View Post
Hey bozzie, what would be your target with this stock?
Good question.
Zero without FDA approval
Low 2's $ as we get close
Nothing below 5 $ with approval and that is very very conservative and would make them a billion dollar company.
It depends on the FDA trial morality rates, the market opportunity is 3 billion in the US alone.
At one point a company called Medwell had a rating on these guys at 5,10 and 22 dollars but the analyst covering them left medwell and so did the rating and his coverage.
There is a lot to factor in including the test for endotoxins (approved) and a stand alone pump the company is trying to get approval from the FDA as well.
__________________
peace

Last edited by Bozzie; 02-18-2016 at 03:23 PM.
Reply With Quote
  #47  
Old 02-19-2016, 10:56 AM
Bozzie Bozzie is offline
Sweet action
 
Join Date: Sep 2005
Posts: 6,876
Rewards: 1,215
Post Thanks / Like
Likes (Given): 606
Likes (Received): 701
Worth a listen if this is interesting to you.
The last 4 mins of the cast the the researcher talks about targeted therapies and identification of population for treatment.. i'm pretty sure he is referring to the study EDT is doing.

Podcast: Why we should all know more about sepsis - On Medicine
__________________
peace
Reply With Quote
  #48  
Old 02-20-2016, 10:35 PM
Bozzie Bozzie is offline
Sweet action
 
Join Date: Sep 2005
Posts: 6,876
Rewards: 1,215
Post Thanks / Like
Likes (Given): 606
Likes (Received): 701
Coverage.
Thomson Reuters Stockreport from TD Financial has moved the rating for EDTXF into "Buy" from "Hold".
__________________
peace
Reply With Quote
  #49  
Old 02-22-2016, 02:06 PM
nutty_bar nutty_bar is offline
Registered User
 
Join Date: Aug 2010
Posts: 220
Rewards: 1,463
Post Thanks / Like
Likes (Given): 1
Likes (Received): 49
Why isn't this stock attracting any interest and volume this late in the game... Something is strange about this. How well in dept do you know about this company? I've learned in the past, in situations like this... Typically the public is "ALWAYS" late to get in... I've been following this stock (EDTFX) since I came across this thread, and there's no volume at all on this stock. Typically, stock prices and volume should be on the rise as of late with all this going on regarding the company... Fishy. I would thread with caution my friend. Don't be the guppy in the ocean of sharks. Be careful.
Reply With Quote
  #50  
Old 02-22-2016, 08:16 PM
Bozzie Bozzie is offline
Sweet action
 
Join Date: Sep 2005
Posts: 6,876
Rewards: 1,215
Post Thanks / Like
Likes (Given): 606
Likes (Received): 701
Yes, the volume is low and has been for many years.
The things i'm looking at here are the following.

The efficiency numbers, if you believe in the company investor presentation are well within what the FDA would want for approval.

Company insiders exercising options this late in the game is a great sign.

The bought deal for 10 million this late in a phase 3 trial.

The trial being reduced earlier this year from 350 to 176 was a great sign the FDA is satisfied with the progress.

The new Mackie and Rutgers analyst coverage and ratings.

The FDA agreeing to compassionate use pre approval.

There are a few more reasons i won't go into here.

I've been buying since this was 14 cents and i do understand the risks, i'm not sure what to say about volume, it's a tiny company on the Toronto exchange who is for some reason adverse to PR Plus the stock is priced so low many funds and managers can't touch it because of price minimums , BTW the OCT is a piece of shit market and hands off for many houses.

We are still 10 months out, i would expect the volume to slowly increase over the next few quarters.

I wouldn't invest unless you are OK with a all or nothing scenario nutty.

Good luck to use both.
__________________
peace
Reply With Quote
Reply

Thread Tools
Display Modes

Posting Rules
You may not post new threads
You may not post replies
You may not post attachments
You may not edit your posts

BB code is On
Smilies are On
[IMG] code is On
HTML code is Off

Forum Jump


All times are GMT -5. The time now is 11:21 AM.


Powered by vBulletin® Version 3.8.11
Copyright ©2000 - 2017, vBulletin Solutions Inc.
Resources saved on this page: MySQL 15.00% Host: cappersmallweb2