Thanks for the post.
I'm aware of the two multicenter trials. The first study of 100 patients, was actually only 43 patients (18 treated, 25 control), due to an error in randomization. Also, if you look at all 43 patients, there was no statistical difference between treated and control for survival (this data is hard to find). When you look at a small subset, there is a difference between patients with high cytokine levels. This study was concluded in 2011, and has not yet been published. Do you really think it will be published at this point?
For the dosing study in progress, I already pointed out that the update at 28 patients was extremely vague, saying the mortality was similar to the control arm in the 100 patient study. This does not make me hopeful the addition of 22 more patients will show a trend in survival benefit.
The other studies for sepsis that are recruiting, S20.111-1 and 2 are only 20 patient studies and one of them is uncontrolled.
It's great there's a lot of studies, but the criticism is there's not a large scale trial that shows clinical benefit. Yes, it shows it reduces cytokine levels, but as far as I'm aware, that is not an acceptable end point per the FDA, to replace 28-day mortality. There is evidence to support that high IL-6 correlates to increased mortality, but not the reverse, that reduction leads to better patient outcomes.
Also, yes it's great that they are working with well-known hospitals. Every drug that is approved also conducts their trials in well-known hospitals with well-known investigators. Do drugs still fail? yes...
I've held this stock for 3 years, but now I'm done waiting. I am not really not happy with how management has handled things. If you still believe, then best of luck. As I said before, I will reevaluate after dosing study results come out.
