Under the GAIN (Generating Antibiotic Incentives Now) there are incentives for the development of antibiotics and antifungals that target life threatening and serious infections. Brilacidin received the Qualified infectious disease product (QIDP) designation for meeting the necessary criteria under the GAIN statute.
Brilacidin is thus eligible for priority review and fast tract designation, as well as an additional 5 years of patent protection.
This is under Title VIII of the Food and Drug Administration Safety and Innovation Act of 2012
It is not an opinion by the FDA as to an outcome of the P3 clinical trial. It is a collection of incentives for CTIX to develop a drug which targets included pathogens, in this case "resistant gram positive pathogens, including methicillin-resistant Staphylococcus aureus, vancomycin resistant Staphylococcus aureus".
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