Cleveland BioLabs (Nasdaq:CBLI) Trading Down 35% After Negative Update
Posted on April 04, 2012 at 11:28 AM EDT
Shawshank, VA 4/4/12 ( StreetBeat ) -- Cleveland BioLabs, Inc. ( Nasdaq:CBLI ) today announced that the Company received a response from the Biomedical Advanced Research and Development Authority of the Department of Health and Human Services (BARDA) indicating that BARDA has declined to invite the Company to submit a full proposal at this time for continued development funding of CBLB502 as a radiation countermeasure. Notwithstanding this notification, the Company plans to continue the development of CBLB502 as a radiation countermeasure without interruption. Yakov Kogan, Ph.D., MBA, interim Chief Executive Officer stated, "There is currently no FDA approved countermeasure for Acute Radiation Syndrome (ARS), and we believe that CBLB502 is the most effective and furthest advanced drug candidate for treatment of ARS caused by exposure to radiation from a nuclear or radiological weapon or from a nuclear accident. We will keep pursuing additional funding from various governmental agencies, including BARDA and our existing Department of Defense funding partners at the Chemical Biological Medical Systems and Defense Threat Reduction Agency." In addition, the Company today announced continued communications with the U.S. Food and Drug Administration (FDA) with back-to-back scheduled meetings in April regarding animal models and remaining human studies. A letter from the FDA's Division of Medical Imaging Products received in late 2011 stated that the CBLB502 "development program continues to meet the expectations associated with the Fast Track designation." In accordance with the Fast Track designation, the FDA already held or has scheduled a number of meetings with CBLI, beyond the standard entitled meetings, to facilitate the definition of the development pathway for CBLB502 as a radiation countermeasure. Ann Hards, Ph.D., Executive Vice President of Regulatory Affairs and Quality Assurance, commented: "We greatly appreciate the flexibility shown by the FDA in assembling the appropriate people needed to reach agreement on CBLB502's development program, including the granting of back-to-back meetings. The presence at our meetings of personnel from the Offices of New Drugs, Medical Policy and Counter-Terrorism and Emergency Coordination, in addition to the Division of Medical Imaging Products, is helping us expedite our navigation through the relatively unchartered waters of the Animal Rule." "The critical unmet medical need for an ARS treatment was underscored by President Obama's recent remarks at the Nuclear Security Summit in Seoul, South Korea," added Dr. Kogan. "At the summit, President Obama noted that the potential for extremists to detonate a nuclear weapon or radiological 'dirty bomb' is still among the most significant dangers facing the international community." Please contact www.thestreetbeat.com for interest in our latest investor relations platform the “CEO Interview Series” with its host Steve Kanaval. The package includes a one-on-one interview with a seasoned industry professional; published segment to our web site with embedded audio/video file; and a compressed file that can be easily e-mailed out to your current and/or potential investors. Please e-mail email@example.com or call (662) 392-0740 for pricing and scheduling. StreetBeat Disclaimer Distributed by Viestly
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