CytoSorbents Corporation (CTSO)

[techxen]

Gottlieb and FDA vs Pentagon

FDA Commissioner Scott Gottlieb, M.D., has hit back at plans that could see the Pentagon take control over the approval of some experimental drugs and devices for soldiers.

https://www.fiercebiotech.com/biotech/gottlieb-don-t-take-away-fda-s-drug-device-approval-remit-for-soldiers

"Some have criticized the plans for undermining the FDA. This issue has centered on the FDA’s rejection of freeze-dried plasma, something the Pentagon says is necessary to save the lives of military personnel.

“FDA has been working closely with DOD to bring freeze-dried plasma to our troops and anticipates that these products will be fully approved for safe and effective use for our armed forces as early as 2018,” an agency official told Politico this week."

This was from Cytosorbent's presentation at the MILITARY HEALTH SYSTEM RESEARCH SYMPOSIUM:

HemoDefend™: Fresh Whole Blood and Universal Plasma Transfusion: Fresh whole blood (FWB) is considered by most military healthcare experts to be superior to blood component transfusions, such as packed red blood cells, in terms of its ability to restore blood volume and to stop bleeding in trauma. An additional advantage of FWB is that it can be directly given by a “walking donor” to the victim at the site of the accident, without the normal logistics and supply chain issues of refrigerated blood. Freeze-dried plasma is another important tool used to resuscitate trauma victims that can be easily carried without the need to refrigerate it. However, the presence of anti-A and anti-B blood group antibodies in both FWB and plasma can lead to dangerous transfusion reactions, therefore requiring very stringent blood-type and antibody level testing. The company highlighted data from the development of new sorbents under the HemoDefend™ brand that are capable of reducing these antibodies from both fresh whole blood and plasma in an ongoing R&D program.

Looks like this may push the FDA to take a look at the HemoDefend solution as a way to get this in place for military use.