Replies to post #5452 on CytoSorbents Corporation (CTSO)

[andy55q]

Why have clinical trials in sepsis failed?
Highlights
•The biology of sepsis is complex and not specific to infection.
•Clinical criteria do not adequately delineate patients who will benefit from specific therapies.
•Stratification systems are needed to guide optimal treatment decisions.
•Success in developing new treatments will necessitate new collaborative research models.
The systemic inflammatory response is biologically complex, redundant, and activated by both infectious and noninfectious triggers. Its manipulation can cause both benefit and harm. More than 100 randomized clinical trials have tested the hypothesis that modulating the septic response to infection can improve survival. With one short-lived exception, none of these has resulted in new treatments. The current challenge for sepsis research lies in a failure of concept and reluctance to abandon a demonstrably ineffectual research model. Future success will necessitate large studies of clinical and biochemical epidemiology to understand the course of illness, better integration of basic and clinical science, and the creation of stratification systems to target treatment towards those who are most likely to benefit.
http://www.cell.com/trends/molecular-medicine/abstract/S1471-4914(14)00009-4

[andy55q]

Scientific and clinical challenges in sepsis.
Ulloa L1, Brunner M, Ramos L, Deitch EA.
Author information
Abstract
Advances in intensive care and antibiotics have prevented the spread of some infections, though sepsis mortality rates remain high. With failure of over thirty clinical trials, sepsis remains a scientific and clinical challenge in modern medicine. Sepsis is defined by the clinical signs of a systemic inflammatory response to infection. "Severe sepsis" is when these symptoms are associated with multiple organ dysfunction. These definitions of sepsis may be too broad and common to heterogeneous groups of patients who do not necessarily have the same disorder. This consideration has become especially evident in the clinical trials that have failed to obtain consistent results in similar studies of patients diagnosed with severe sepsis. In these trials, patients with infections caused by different microorganisms, and affecting different organs, have been combined under the general diagnosis of severe sepsis. The situation is analogous to attempting a clinical trial based on the general definition of cancer, combining all patients with tumor independent of the type of malignancy. In this consideration, it would not be very surprising that activated protein C, the only treatment in sepsis approved by the Food and Drug Administration, is projected for use in only a small subset of patients with severe sepsis. This article reviews novel inflammatory molecular aspects and the experimental anti-inflammatory strategies for sepsis, as they may represent particular pathological processes in specific subsets of patients.

[chrisgold]

As you can see from the links i posted that getting into SEPSIS market and approvals are not easy for anyone ....but why i think purely my opinion that DIAGF and CTSO are undervalued and underestimated is other bios with xero revenue are traing way higher...but i do undertand getting hold in sepsis market is not that easy...jmho..glta..long ctso and diagf so can't bash but not pumping either as posts on these board really can't move the price :))) they are just opinions or views of small investors :::))

[chrisgold]

BMA and PROUDAMERICAN can you answer ......low success rate or zero for sepsis trails now and what are the cahnces of CTSO and DIAGF...

[BuyMyAsk]

I agree Chris. FDA approval for this will be difficult. I believe that is why they are going for cardiac surgery instead of sepsis. They already have essentially 2 failed trials that couldn't prove the device helped people survive who had sepsis. They could not afford to have a 3rd trial fail with the FDA. It would send the stock to the floor.

I am baffled at todays PR and Dr. Chan STILL SAYING they are going to uplist to a national exchange later this year. They have around 6 months left. The cost of uplist annually is a huge expense for the company. If they do a 20/1 reverse split and the stock is able to get shorted the hedge funds will eat this thing alive. It would be the worst thing Dr. Chan could do at this point. You should never uplist if the fundamentals arent in place.