CytoSorbents Corporation (CTSO)

[raptorjockey]

The FDA had their chance when we applied for the EAP Program. Our application was turned down by the FDA because we were targeting Sepsis, and they had recently been burned by Eli Lilly, when Lilly voluntarily pulled the Drug, Xigris. "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." From this point forward, the FDA arbitrarily insisted that all treatments designed to treat Sepsis be subject to the 28 Day Mortality Test, even though this requirement flew directly into the face of the intent of the Expedited Access Pathway Program. There are currently 15 members of Congress who are Physicians. They do respond to constituent letters. A polite note to them inquiring why Cytosorbents filter was turned down by the FDA for the EAP Program, given its successes in the EU, is well worth a closer look. Here is the list of Physicians in Congress:
beckershospitalreview.com/hospital-management-administration/meet-the-15-physician-members-of-the-115th-us-congress