Cleveland BioLabs cuts losses while awaiting FDA meeting - The Buffalo News

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Cleveland BioLabs cuts losses while awaiting FDA meeting

Cleveland BioLabs cut its operating losses in half during the first quarter as the Buffalo drug development company slashed its operating costs and narrowed its focus to the development of key anti-radiation sickness and cancer drugs.

But the company’s most advanced drug candidate, which could be used to treat radiation sickness, remains in limbo as the company awaits a key meeting with federal regulators in July on the potential stockpiling of its Entolimod drug for emergency use, such as a nuclear power plant accident or terrorist attack.

The company is preparing for a session with the FDA during July to discuss the data that the FDA would require in an application under the program, said Yakov Kogan, Cleveland BioLabs’ chief executive officer, during a conference call Thursday.

The meeting with the U.S. Food and Drug Administration to discuss using a process, known as a Pre-Emergency Use Authorization, that could allow the government to stockpile unlicensed drugs “is paramount for us” because that drug is the furthest along in its development and the closest to becoming a revenue source, Kogan said.

The company cut its operating loss by 53 percent to $3.5 million during the first quarter as the company slashed its research and development spending by 54 percent by shifting some of its personnel to an affiliated company and narrowing its research focus.


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