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Cleveland Biolabs (CBLI) Reports Delay in Analysis of Biocomparability Data Required for Regulatory Submission



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Cleveland BioLabs, Inc. (NASDAQ: CBLI) today reported that the company has received vendor notification of delays in analytical analyses of a formulation biocomparability study required for the Company’s regulatory submissions. These delays oblige CBLI to withdraw the entolimod Marketing Authorization Application (MAA) that the company had previously submitted to the European Medicines Agency (EMA) because a complete response to certain questions raised by the EMA cannot be prepared in the timeframe required by the EMA review process. Because the review by the United States Food and Drug Administration (FDA) of the company’s pre-Emergency Use Authorization application does not take place on strict timelines, entolimod’s review status with the FDA is unaffected.

Upon receipt of the vendor notification regarding the delays, the company informed the EMA of the MAA withdrawal. The company is working with the vendor to resolve the issues leading to the delayed analyses of the biocomparability study. While that work is ongoing, company personnel remain blinded to the study data.

Ann Hards, Ph.D., Executive Vice President of Regulatory Affairs, commented, “In reviewing the MAA, the EMA required that CBLI provide information regarding the biocomparability of the entolimod formulation used in studies and the formulation proposed for commercialization. The FDA had also requested this same information during their review of our pre-Emergency Use Authorization application. Because we cannot now provide that information within the time-frame required by the EMA, we must withdraw our MAA. Once we have compiled the biocomparability data, we can better determine next steps.”

Yakov Kogan, Ph.D., MBA, Chief Executive Officer, stated, “While we are disappointed with the delay in receiving the results of the biocomparability study, we can continue our prosecution of the pre-EUA with the FDA once those results are available. We will also consider the most appropriate timing for resubmission of the MAA in the European Union.”


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