The regulatory evaluation follows a direct request from the Ukrainian government, signaling a strategic shift toward securing medical supplies for radiological emergencies. By utilizing a "recognition" pathway, the Ministry of Health may complete its technical review in 45 to 60 days, depending on the scope of information requests. This process relies heavily on the drug’s development status under the U.S. Food and Drug Administration, where it is currently being studied under the Animal Rule for its ability to provide dual-system protection for the hematopoietic and gastrointestinal tracts.

Valion Bio has prepared for potential procurement demand through its subsidiary, Velocity Bioworks. The company has demonstrated a manufacturing scale-up capable of producing approximately 1.3 million doses, ensuring readiness for national stockpile requirements. CEO Michael K. Handley noted that the submission serves as a critical step in expanding the reach of Entolimod beyond U.S. domestic programs, offering a specialized alternative to traditional growth-factor therapies that often fail to address lethal gastrointestinal damage caused by high-dose radiation.