Statera BioPharma Inc (STAB)

[zino]

We continue to discuss requirements for submission of a Biologics License Application (BLA) for entolimod with the FDA. In addition, a pre-Emergency Use Authorization, or pre-EUA dossier for entolimod has been submitted to the FDA for review.

Products with pre-EUA status can be purchased by the US government for stockpiling in the event of a disaster. The FDA granted entolimod both Fast Track and Orphan Drug status for reducing the risk of death following a potentially lethal dose of total body irradiation during or after a radiation disaster http://www.cbiolabs.com/entolimod-cblb502-biodefense/