Cleveland Biolabs Inc. (CBLI) Receives FDA Agreement on Pivotal Animal Efficacy Studies for Development of CBLB502 (Entolimod) as Radiation Countermeasure
9/10/2012 9:10:03 AM
BUFFALO, N.Y., Sept. 10, 2012 (GLOBE NEWSWIRE) -- Cleveland BioLabs, Inc. (Nasdaq:CBLI) today announced the receipt of an Advice Letter from the U.S. Food and Drug Administration (FDA) indicating agreement with proposed pivotal animal efficacy studies for the development of CBLB502 (Entolimod™) as a radiation countermeasure. The FDA also accepted the Company's recently concluded Good Laboratory Practice non-human primate (NHP) study as part of the pivotal program.
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