Brief: Cleveland BioLabs provides update on pre-EUA review of Entolimod as radiation countermeasure

Statera Biopharma

16/03/2016 18:03

March 16 (Reuters) - Cleveland Biolabs  CBLI.O  
    * FDA indicated further review of pre-EUA dossier would not 
proceed until bio-comparability data have been evaluated by 
agency 
    * Design of bio-comparability study currently in 
development, will need to be agreed upon with FDA before study 
is executed 
    * Pre-EUA review of Entolimod as radiation countermeasure 
    * A meeting was held with FDA to discuss various aspects of 
Entolimod manufacturing 
 
Source text for Eikon:  urn:newsml:reuters.com:*:nMKWJ0pXDa 
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