Microbiome Therapy Firm’s COVID-19 Medical Food Research Landed On US FDA’s Drug Study Menu
Executive Summary
Medical food is “for the specific dietary management of a disease or condition for which distinctive nutritional requirements … are established by medical evaluation,” but no distinctive nutritional requirements are established for COVID-19, FDA says. Kaleido says in SEC filing that it “intends to continue with its plans to submit an IND for KB109 in support of future clinical research.”