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FDA request for more study delays Cleveland BioLabs drug approval

Federal regulators have dashed Cleveland BioLabs’ hopes for a quick approval for its anti-radiation sickness drug.

Regulators from the U.S. Food and Drug Administration have told the company that it will require another study before it will consider Cleveland BioLabs’ request that its Entolimod drug be approved so that it can be stockpiled for use in an emergency, such as a terrorist attack or a nuclear accident.

Company executives saw the application for emergency use as a way that the cash-strapped company could generate revenue from the drug while it moves ahead with the longer and more costly process of gaining conventional approval for non-emergency use.

But the FDA told the company that it will require an additional study to examine the impact of differences in Entolimod’s drug formulation during previous studies. Those earlier studies have indicated that the drug could be an effective treatment for people who have been exposed to potentially lethal doses of radiation, even if the drug is administered a day after the exposure.

Yakov Kogan, Cleveland BioLabs’ CEO, said that the request for the new study has “temporarily slowed” the company’s efforts to bring Entolimod to the market but that it remains “fully committed” to the drug’s development.

Kogan did not estimate how long the new study would take. The company and the FDA still need to agree on the scope of the study.

The delay caused Cleveland BioLabs’ stock to fall by 19 percent, or 71 cents, to $2.95 in late trading Tuesday. On Thursday, the stock closed at $2.54, down by 41 cents, or 13.9 percent.

Cleveland BioLabs last year had been months away from running out of cash, but the company solidified its financial position last year by selling a majority stake to a Russian investor for $25 million and securing $15.8 million in federal funding to help pay for studies to measure the effectiveness of the anti-radiation sickness drug.

Cleveland BioLabs executives said in February that the company has enough cash to fund its operations for more than a year.