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  #276  
Old 07-13-2017, 08:25 AM
Bozzie Bozzie is offline
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Then again i have a plan to sell a small amount if it moves up before September.
I feel a little trapped in this right at this point.

I don't know fellas i'm calling this a toss up, Just too little info to look at it any other way.
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  #277  
Old 07-24-2017, 11:29 AM
nutty_bar nutty_bar is offline
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Looks like great news today!! Moving forward quietly, I like that.
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  #278  
Old 07-24-2017, 11:59 AM
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Looks like great news today!! Moving forward quietly, I like that.
great news.. now i can sell a little hopefully
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  #279  
Old 07-25-2017, 02:09 AM
nutty_bar nutty_bar is offline
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Why would you want to sell at this point? Isn't this slowly moving in the right direction?
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  #280  
Old 07-25-2017, 06:56 AM
Bozzie Bozzie is offline
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Why would you want to sell at this point? Isn't this slowly moving in the right direction?
i think the risk is high and i own a ton.. I bought some a while back with the intention of selling.
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  #281  
Old 07-31-2017, 12:14 PM
nutty_bar nutty_bar is offline
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I found this article:

More than 100 randomized clinical trials have been conducted in the hopes of finding a safe and effective treatment for sepsis. In 2011, Eli Lilly (NYSE:LLY) withdrew its previously approved sepsis drug, Xigris, from all markets after the drug, approved a decade previously with a statistically significant efficacy of 6%, failed to replicate the same result in a clinical trial of 1,696 patients.
Recently Spectral Medical, Inc. (OTCPK:EDTXF), a small Canadian company, released trial results for its sepsis treatment (EAA and PMX). While this treatment is not a drug, but a medical device, the same standard of proof for efficacy still applies: a statistically significant mortality benefit at 28 days.
Spectral’s trial, called the EUPHRATES (Evaluating the Use of Polymyxin B Hemoperfusion in a Randomized controlled trial of Adults Treated for Endotoxemia and Septic shock), studied severe sepsis patients with septic shock, meeting the trial criteria of endotoxin activity assay (EAA) measurement ≥0.6, and a multiple organ dysfunction score (MODS) > 9 (which translates as having three organ failures). While the trial was powered to show a 20% efficacy in the per protocol group, it only reported 5%, which did not achieve statistical significance.
In a post hoc analysis of the trial data, some subgroups were shown to have achieved a better mortality benefit: 10.7% in patients with 0.6 ≤ EAA < 0.9 (n=194); and 21% in patients where no bacteria could be identified by culture (n=59). However, it is important to note that neither of these numbers are statistically significant according to the pre-approved statistical analysis plan (which requires 360 patients to show a statistically significant 15% benefit and approximately 1,200 patients to show a statistically significant 7.5% benefit).
In its post hoc analysis, the company claims that by using the data from a "modified" per protocol group, not the original, which excludes patients with EAA>0.9 and under a "modified" statistical method (when "baseline APACHE and mean arterial pressure were controlled in each arm"), these mortality benefits become "statistically significant." Considering the fact that sepsis is perhaps one of the most studied unmet medical needs, it is very doubtful that both these post hoc modifications are valid ways to establish the required statistical significance.
Over 1 billion dollars (US) have been spent on sepsis trials over the past decades to find a treatment and none have succeeded, except for Eli Lilly’s Xigris mentioned above. It defies logic that no company over the past decades, which, having conducted a large (thus costly) sepsis trial, would not have done what Spectral now proposes to do. For example, why would Eli Lilly attempt a large study of 1,696 patients to prove a 6% efficacy when a mere 194 patients can be sufficient to prove a statistically significant 10% according to Spectral Medical, Inc.? Indeed, if it is possible to simply modify the per protocol group as well as the statistical method post hoc to show a "better" trial result, the failure rate of over 90% in phase 3 drug trials could be greatly reduced.
Perhaps more importantly, the post hoc analysis of the trial result did not identify any possible cause for the much-lower-than-expected efficacy. Only 59 out of 244 patients had the expected 20% efficacy, and the PMX treatment did not work effectively in the remaining 185 target patients (the majority). Nor did post hoc analysis offer any significant steps by which the trial protocol might be improved (i.e. to show a better efficacy) besides a possible amendment in the protocol to exclude patients with EAA>0.9 (n=50, in which the PMX group has a higher mortality rate than the sham group). It is of note that the adverse effect on mortality in this n=50 subgroup was not addressed by Spectral’s team.
The variable which defined the best responding sub-group (i.e. n=59) within the trial is not useful in that this cannot be used as an additional selection criteria. For example, a culture to identify those sepsis patients who have no bacteria will most likely take longer than 24 hours. This further delay will no doubt adversely interfere with one very significant known factor in PMX treatment, namely that of "early" intervention. Indeed, the successful PMX trials that were done without the EAA assay as a selection criteria, unlike the EUPHRATES trial, stressed early intervention. Therefore, in reality, it will be impossible to identify which patients fall into this subgroup.
In his article on sepsis, Prof. Jean-Louis Vincent states that there are 170 biomarkers that have been proposed and assessed clinically in relation to sepsis. Given the complexities and the heterogenous nature of sepsis patients, Prof. Vincent states, "I do not believe that a single marker will ever be of use alone." Here perhaps lies the greatest limitation of Spectral’s trial and treatment: it is a protocol and a treatment of a single marker namely endotoxin. The EAA assay is all about measuring endotoxin level, and PMX is all about removing endotoxin.
In Japan, where the PMX treatment has been approved since 1994, the national sepsis guidelines state that endotoxin does not play a key role in sepsis pathology and therefore the effectiveness of a treatment such as PMX that removes only endotoxin as its mechanism of action is doubtful. In another review article about extracorporeal blood purification for sepsis, the authors similarly doubt the usefulness of these techniques, stating that "in severe sepsis, source control, early appropriate antibiotics, and haemodynamic support are the three most important treatment components." Simply put, the PMX treatment is removing only one of many biomarkers, which does not play a central or critical role in treating sepsis. In their conclusion on the use of blood purification techniques which includes PMX, the committee which works on the Surviving Sepsis Campaign, a committee which includes the principal investigator for the EUPHRATES trial, Dr. Phillip Dellinger, states (Section K): ‘In consideration of all these limitations, our confidence in the evidence is very low either in favor of or against blood purification techniques; therefore, we do not provide a recommendation. Further research is needed to clarify the clinical benefit of blood purification techniques.’ Finally, in a July 2017 Journal of Intensive Care, Letter to the Editor, commenting on the EUPHRATES trial results, the authors rightly concluded that "since this favorable effect was obtained from 'post hoc' analysis, further study is expected."
In conclusion, the EUPHRATES trial failed to meet its primary end point, and therefore the efficacy of the PMX treatment protocol using EAA assay as a patient selection tool remains unproven. There is no precedent for the FDA approving a treatment for sepsis, be it a drug or a medical device, that has no proven efficacy according to a statistically significant mortality benefit at 28 days.

What are your thoughts? This guy sounds like he knows what's going on.
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  #282  
Old 07-31-2017, 02:58 PM
tigerman19 tigerman19 is offline
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I read last week when it dropped one day. Went back up next day. That's actually a woman's opinions. Her and her husband are biotechs with PhD's. She said they invest in biotech. She did say they don't have an opinion on spectral.
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  #283  
Old 08-15-2017, 10:20 AM
Bozzie Bozzie is offline
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Succinct little report.
I like it.

Read the disclosure at the bottom as well.


https://gmpsecurities.bluematrix.com...om&source=mail
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Last edited by Bozzie; 08-15-2017 at 10:21 AM.
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  #284  
Old 08-15-2017, 11:45 AM
tigerman19 tigerman19 is offline
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Been several other articles out basically saying approval is dead.
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  #285  
Old 08-15-2017, 12:37 PM
Bozzie Bozzie is offline
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The Seeking Alpha opinion?
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  #286  
Old 08-22-2017, 11:58 PM
tigerman19 tigerman19 is offline
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Sorry so long. Yes, I believe it was that one.
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  #287  
Old 09-19-2017, 05:11 PM
nutty_bar nutty_bar is offline
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Anyone know what's up with this company? Any important dates coming up?
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