Cleveland Bio's accelerated regulatory clearance for entolimod delayed by FDA-required bio-comparability study; shares off 27%

|About: Cleveland BioLabs, Inc. (CBLI)|By:, SA News Editor

Thinly traded nano cap Cleveland BioLabs (CBLI -26.7%) slumps on an 11x surge in volume in response to its announcement that its pre-Emergency Use Authorization (pre-EUA) application for entolimod as a radiation countermeasure will be delayed in order for an additional study to be conducted. The aim of the study, required by the FDA  before reviewing the application, is to establish bio-compatibility between the entolimod formulation proposed for use as a radiation countermeasure and the formulation used in earlier preclinical and clinical studies. Its design is currently under development and will need the FDA's sign-off before commencing.

The new timeline for the pre-EUA submission has yet to be finalized. The company says it will do what is necessary to get the filing under regulatory review as soon as possible.

Shares rallied in 2014 on the news that the pre-EUA filing could proceed based on existing safety and efficacy data and animal-to-human dose conversion.

Previously: Cleveland Bio up big after report of positive FDA opinion on entolimod (Sept. 3, 2014)

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