$heff's $tation of $tocks & $olid DD

[kei]

CBLI - BUFFALO, NY--(Marketwired - Sep 21, 2015) - Cleveland BioLabs, Inc. (NASDAQ: CBLI) today announced that the Department of Defense (DoD) Congressionally Directed Medical Research Programs (CDMRP) Peer Reviewed Medical Research Program has awarded CBLI a research grant valued at up to $6.6 million to fund a clinical trial designed to support a Biologics License Application (BLA) for entolimod. Entolimod is a novel, broad-spectrum investigational drug being developed to reduce the risk of death following exposure to potentially lethal irradiation occurring as the result of a radiation disaster.

This award follows a $9.2 million contract from the DoD CDMRP Joint Warfighter Medical Research Program, awarded on September 1, 2015, to fund pivotal animal studies with entolimod supporting the same indication.

Yakov Kogan, Ph.D., Chief Executive Officer for Cleveland BioLabs, stated, "We are committed to pursuing full marketing approval for entolimod as a medical radiation countermeasure. With this new award, we now have up to $15.8 million in development funding from the DoD to generate additional data supporting a BLA submission."

"In the meantime," continued Dr. Kogan, "our pre-Emergency Use Authorization (pre-EUA) dossier is currently under active review with the US Food and Drug Administration (FDA). Pre-EUA is the regulatory path through which the FDA determines that certain unapproved medical products may be used in an emergency when there are no adequate, approved, and available alternatives. Products with pre-EUA status may be purchased by certain US government stakeholders for stockpiling in the event of a disaster."
http://finance.yahoo.com/news/department-defense-grants-cleveland-biolabs-113000516.html