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  #201  
Old 10-03-2016, 07:22 PM
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I know everyone is down and depress with what happened today. But this is definitely not the end, there will be a re-trial stage with more columns being use. This is probably the best price to buy. Read this article below.

https://www.google.com/amp/www.foxne...?client=safari
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  #202  
Old 10-03-2016, 10:31 PM
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I agree, obviously a massive setback and a kick to the nuts today, but great things are worth waiting for. May toss a few more bucks in and let them fly for a while.
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  #203  
Old 10-03-2016, 10:44 PM
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Idk if I'm crazy or a sucker for pain, but I also thought bout buying more at this price haha
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  #204  
Old 10-03-2016, 10:47 PM
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We have to realize that this is a medical device, not a drug. This devise is already approved in Japan, Europe, and Canada. And as the report states, it Does show beneficial when used. The clinical trial is with 2 columns used. What if more columns are used for a retest? I think its just a matter of time for an approval.
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  #205  
Old 10-04-2016, 12:56 AM
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Sdi.to

Damn terrible news. Had no stop loss set either was going hold no matter what.

Might just average down now.
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  #206  
Old 10-13-2016, 12:07 PM
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I sold out on the way down and minimized my loss.. thankfully i had a 33 cent average SP.
I don't think this is over and have a buy in at 16 cents american.
My feeling is there will be no news for a few months as the company untangles the data and with that the price will slowly decline.

Here are a few thoughts from a buddy

Euphas was only for patients with abdominal sepsis who underwent emergency surgery for intra-abdominal infection. Euphrates was done on all septic shock patients regardless of where the infection was based, so urinary, lung infections, etc were also included. Long story short, maybe only 2 PMX cartridges are needed for abdominal infection because the surgery stopped the endotoxin source, but when the infection is pneumonea or urinary tract, then you need to just keep using cartridges until the infection is neutralized by antibiotics, and the EAA can be brought down. I am hoping that when spectral analysizes the data that they find that abdominal patients saw a good mortality improvement similar to Euphas. I'm basically hoping that the 18% number is the abdominal patients just like in Euphas because then you can pull those patients out and combine their data with Euphas to get a much stronger statistical argument. It's almost like the FDA wanted this trial to answer way too many questions and cover too many different kinds of places were the infection starts.

If Spectral is able to do what I just described than maybe they can get FDA approval for abdominal septic patients first, and approval on the other types of infection is just going to have to wait until observational studies prove that more cartridges is effective. I know abdominal only, really hurts our market potential but it's still something of value and then eventually they can get approval for the other types of infection source.
Euphas 2 shows the incidence rate of abdominal sepsis at 42-44%. So if Euphrates can confirm Euphas 1 & 2 on just the abdominal patients, then spectral should be able to get approval. So instead of going after a 3 billion dollar space, we will be going for 44% of it, which is 1.35 billion. The other 1.65 billion is just going to have to wait until testing with more cartridges. I'm starting to think that the DSMB and FDA knew the whole time that getting statistical significance was impossible when you combine the abdominal with the non-abdominal. They just wanted Spectral to get as much data as possible on both groups and then analysis on each group could be separated after that. The FDA was wanting 2 things I think, confirmation on the abdominal patients, and information on the non-abdominal. They basically used Paul and Spectral by misleading them to believe that they were hitting their numbers because they wanted the data. Misleading might be the wrong word because I do believe Spectral will get approved for abdominal if the abdominal subset matches anything close to Euphas 1 & 2.
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Last edited by Bozzie; 10-13-2016 at 12:09 PM.
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  #207  
Old 10-13-2016, 12:09 PM
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I'm still totally baffled by the DSMB's actions over the course of this trial but now I'm all hung up on the FDA's actions. Specifically, why in the world would the FDA allow Spectral to do a Modular PMA submission so early? We were granted the modular format back in April 2015. Back then we all thought Spectral was going to need 650 patients total. In other words we were 2.5 years away from being fully enrolled. I'm no regulatory expert but that seems awfully early to be starting a modular PMA. What was the FDA thinking in allowing us to start a modular so early? There was a 3rd interim planned for late 2015 that theoretically could have stopped the trial early for efficacy, but as we now know, the top line data was never pointing towards a positive result, and the DSMB knew this all along. Hell, we would have needed a 30% absolute benefit to stop it at the 3rd interim. So why grant a modular so early? This is all so strange and I have no concrete argument but it feels like there is a greater power at play here.

My only conclusion to all this weirdness from the DSMB and the FDA is that there must be something hidden in that mountain of data that gives Spectral a decent shot at some sort of approval. Whether it's the abdominal subset or the subset that actually showed endotoxin reduction, I don't know, but there must be something in there for the DSMB and FDA to take the actions they've taken. I can't come up with any other explanation for their actions. I'm not trying to get your and my hopes up, but there must be something hidden in there. There are just too many super smart guys on the DSMB, they weren't shooting from the hip. The FDA is a regulatory beast, they don't just allow a modular because you've got a nice smile. It's the only explanation I can come up with. We just have to wait until Spectral finishes their detailed analysis I guess. Man this is some crazy Occam's Razor type shit. I'm dying to see what Spectral discovers in that mountain. I don't think it's just a bunch of good secondary benefits either. It must have something to do with that 18%. That's where the breadcrumb trail starts and I feel confident that Spectral will be able to follow it.
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  #208  
Old 10-13-2016, 02:21 PM
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How did you get out on way down? It opened down here around $.20.
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  #209  
Old 10-15-2016, 03:24 PM
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it bounced around a bit after the opening .. I saw trades in the 40 cent range but didn't hit them.. i got out at 28.
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  #210  
Old 11-18-2016, 05:55 PM
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Anybody adding more here? Nearly at its 52 week low.
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  #211  
Old 11-22-2016, 11:23 AM
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Quote:
Originally Posted by skidmarkymark View Post
Anybody adding more here? Nearly at its 52 week low.
I think it has more downside....Tax loss season is here.
Nothing happening till the 1st quarter of 2017
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  #212  
Old 11-22-2016, 12:15 PM
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my brother is in medical sales and this is type of product he sells

we were rooting for it, the whole thing was strange because its as if they knew they wouldnt pass fda with what they presented yet wanted to ruch through it

im going to buy in 1q of 2017 and see if they can fix this down the road
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  #213  
Old 11-22-2016, 05:00 PM
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Ahh ok thanks very much for your insight you two. Will look to 2017.
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  #214  
Old 12-16-2016, 11:00 AM
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So what does this mean in terms of where the company could be heading?

Any insight would be appreciated

http://www.spectraldx.com/assets/spe...s-12.14.16.pdf
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  #215  
Old 12-16-2016, 11:23 AM
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cost cutting measure. it will move to the pink sheets again.
Data is being collected still and i've been told there are a lot of positives.

i bought back part of my position last week.
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  #216  
Old 12-16-2016, 01:27 PM
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Thanks for the info bud. I picked up a bit more a few days ago as well.
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  #217  
Old 12-18-2016, 07:40 PM
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So what if I currently own some of their stock on OTC? What will happen?
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  #218  
Old 12-18-2016, 09:37 PM
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pink or gray market.. you can still trade it.
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  #219  
Old 01-27-2017, 01:55 AM
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A true glutton for punishment but i'm back in at the level that i sold out.
FDA meeting next month is the word
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  #220  
Old 02-08-2017, 08:43 PM
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Worth adding do ya think bozzie? Still holding from the last run waiting on news
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  #221  
Old 02-11-2017, 01:27 PM
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Originally Posted by skidmarkymark View Post
Worth adding do ya think bozzie? Still holding from the last run waiting on news
I don't think its a 10 dollars stock anymore but it could be worth 3 if they can get approval...i still like it but i'm not holding my breath.
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  #222  
Old 02-11-2017, 04:29 PM
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Gram negative negative bacteria are a bitch

In June 2015 I had a gram negative pseudomonas aeruginosa bacteria infection. I was IV treated with Polymyxin B for four or five days. As soon as it was going in, my lips went numb, followed by sensitive areas like inside arms, neck more. I was under constant blood work checks. When it started attacking my kidneys, it was discontinued. There was exactly ONE other antibiotic that was just approved in Feb. That worked. I still get episodes of itchy skin. The bitch is that I then have limited feeling in the skin and if I scratch it, I usually hurt myself by rubbing too hard as I have a bruise on my arm that I hurt. In hospital it was worse. I should have been given cotton mittens and restrained but that breaks some State no-tie-down Laws.

Infection returned last year. A carparpenum resistant gram negative pseudomonas aeruginosa bacteria infection. Big words for a bad actor. I got a different combination of drugs. See http://www.medscape.com/viewarticle/814975

There is only one drug for gram negative bacteria called Polymyxin E or Colistin. It is only mildly effective taken by mouth. Guess what? China feeds 27 million pounds of it to their swine to keep them bacteria free. So there is 27 million pounds of colistin in Chinese hog poop in almost its primary form. This will likely kill half of the world. Forget climate change. Move if its real. By 2040 if you cut your skin, you may die of septis.

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Last edited by AuburnKid; 02-11-2017 at 04:31 PM. Reason: opps, two negatives. only one
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  #223  
Old 02-11-2017, 06:31 PM
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Wow.. you were treated with Polymyxin B.
The spectral product is a membrane coated with Polymyin B that is run through your body Via dialysis machine.
Yes, this is going to be a huge problem the world will shortly face.
The enormity of the problem is one of the reasons i do think approval is possible.

Hang in there buddy.. if you need info on hospitals participating in the post trail use program hit me up on the PM function here at cappers.

Be well Kid
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  #224  
Old 02-11-2017, 07:17 PM
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Teixobactin is the first new antibiotic to be discovered in nearly 30 years

The first new antibiotic to be discovered in nearly 30 years has been hailed as a ‘paradigm shift’ in the fight against the growing resistance to drugs.

Teixobactin has been found to treat many common bacterial infections such as tuberculosis, septicaemia and C. diff, and could be available within five years.

But more importantly it could pave the way for a new generation of antibiotics because of the way it was discovered.

Above is great but only on gram positive like MRSA. I have learned so many anatomy words in looking up cures, many doctors think I was a doctor. I hear "when you practiced, were you in infectious diseases?" The mcr-1 plasmid was just found in Los Angles. Y. pestis coming to your town someday. Right now if you get infected with a gram negative bacteria that Colistin cannot kill, put your affairs in order. Right now I just started a course of Amoxicillin and clavulanate. I see doctor Monday for more tests.

Emergence of plasmid-mediated colistin resistance mechanism MCR-1 in animals and human beings in China: a microbiological and molecular biological study.

see http://thelancetnorway.com/journals/...424-7/fulltext
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  #225  
Old 02-23-2017, 09:45 AM
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February 23, 2017 08:00 ET

Spectral to File Final PMA Module With the FDA for Its Toraymyxin™ Treatment of Endotoxemic Septic Shock
TORONTO, ONTARIO--(Marketwired - Feb. 23, 2017) - Spectral Medical Inc., ("Spectral" or the "Company"), (TSX:EDT) a Phase III company developing the first treatment for patients with endotoxemic septic shock using a medical device, today announced that it plans to file the fourth of four modules of its premarket approval application (PMA) submission, containing the clinical study report, with the FDA for Toraymyxin™ early in the second quarter of this year. The EUPHRATES trial is the first in North America to use a companion diagnostic, the EAA, in the area of sepsis to select patients most likely to benefit from the therapy.
On October 3, 2016, the Company announced that its EUPHRATES trial showed a mortality benefit at 28 days of 5 percent in a pre-specified per protocol patient population with a MODS score greater than nine. This benefit did not reach statistical significance according to the SAP (statistical analysis plan). However, the initial data analyses also showed beneficial treatment effects across multiple secondary endpoints.
Over the last few months a thorough review and analyses of the trial data base has been completed with guidance from the Steering Committee. The information from the EAA measurements has been instrumental in the data review process and has led the Company to its strongly held belief that the Toraymyxin™ column is safe with clinically significant evidence of efficacy. Based on this data review and analyses, the Company has informed the FDA that it plans to submit its final PMA module early in the second quarter of this year, in keeping with the regulatory pathway en route to approval of Toraymyxin™. It is also the intention of the Company to release further detailed results of the clinical trial at a scientific meeting soon after the filing of PMA.
"We are very encouraged by the results of our analyses and the merit of our data. As such, we intend to proceed diligently with our regulatory program. Septic shock continues to claim a significant number of lives each year in North America and no other treatment is currently available for these patients," stated Dr. Paul Walker, President and CEO of Spectral.
For further information on the FDA regulatory process the Company directs readers to the FDA website, including: https://www.fda.gov/MedicalDevices/D.../ucm047991.htm
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