The broad-spectrum activity of Cethromycin enables its development across multiple high-need indications, significantly enhancing the likelihood of successful market entry and clinical impact.
Cethromycin would be eligible for Fast Track and Breakthrough Therapy designation, Priority Review and Tropical Disease Priority Review Voucher (PRV). Additionally, Cethromycin may qualify for various development incentives of the Orphan Drug Act, including tax credits. Last but not least, Cethromycin is active against Qualified Infectious Diseases pathogens, adding 5 years of marketing exclusivity.