CytoSorbents Corporation (CTSO)

[raptorjockey]

Bertha, this article read like deja vu. We filed for EAP Program designation and during the talks with FDA we were told: " Center for Drug Evaluation and Research (CDER) and the Center for Devices and Radiological Health (CDRH) branches of the FDA about the Company’s EAP application, the FDA indicated that 28-day all-cause mortality would be the appropriate primary endpoint regarding CytoSorb and the treatment of sepsis. CDER noted that historically, in many other sepsis trials unrelated to CytoSorb, there has been a lack of utility or correlation in surrogate endpoints when predicting mortality improvement in sepsis outcomes." It was this; "October 25, 2011 — Eli Lilly is withdrawing activated drotrecogin alfa (Xigris), a drug intended to treat severe sepsis in high-risk patients, from all markets including the United States in the wake of a new study showing that the agent did no better than a placebo in reducing mortality." that embarrassed the FDA and subsequently caused the FDA to insist on the 28 day standard no matter drug or device. I think we should have appealed this as it embarrassed lower level employees of the FDA, but we didn't pursue it because we could have ended up on the s**t list of the FDA causing greater problems down the road. In the mean time, I calculate we have 150,000 patients a year that have lost hands and feet due to this decision denying Cytosorbents EAP designation going forward. Yes, I'm still angry about that one!