CytoSorbents Corporation (CTSO)

[Murph1953]

Motality v. cytokines. Why?

There are many, MANY causes of sepsis.
One can fall down in the woods, cut one's hand.
Maybe you could compose a list of 500 different ways, each with its own cause, parameters, presentations, timelines, pharmo-bullets and different mortalities too(?).

Tell me how you would set up a study for that(?).

Madness.

from someone's April 9th post which I archived:

"Do you honestly believe they have delayed obtaining "real" clinical data because they feel their product does not work, and they are just kicking the bucket down the road, stringing us all along? Are all of these independent companies (Fresinius, Biocon, Unknown cardiac partner et al..) and Universities risking their reputations and signing on to collaborate with them based on fluffy data with no substance? Do you believe these companies have done their due diligence and not been privy to more data than you and I? Should board members here put their trust in the advisory board of Fresinius or you? Do you understand how large and EXPENSIVE a clinical trial would need to be prove decreased morbidity and mortality for sepsis? This population is extremely heterogeneous and would likely require massive numbers of patients to control for the numerous ages, disease states and co-morbidities.

I believe Chan wants to keep this product in house and cannot afford to run such a trial on his own right now. He also truly may not totally know what his device is truly capable of. Consequently, they have decided to pursue approval as a cytokine reducer and then focus on a grass-roots movement with independent clinician-led studies to further define what this product can and cannot do and to drive usage (almost like crowd sourcing). Then, once momentum has been established, and they have more data, they will be able to afford a larger trial that is directed towards the appropriate disease state in the appropriate patient population.

They have already achieved this in Europe with the CE mark, and I will be willing to bet their primary endpoint in their FDA trial will be cytokine reduction as well - not reduced mortality or organ failure. The primary focus in Europe will continue to be on sepsis, and the primary focus in the US will be cardiac. Once approved as a cytokine reducer in cardiac procedures in the US, additional indications (such as sepsis) will be easier to achieve.