"This would the first time we have a product starting Phase 1." ......No Kalyterra went all the way to Phase 2 with their GVHD trials, not sure if it was ever completed tho.

ALSO: "Planned IND Submission from June 15, 2020

"Kalytera plans to submit an Investigational New Drug Application (IND) to the Australian Therapeutic Goods Administration (TGA) and the U.S Food and Drug Authority (FDA) for a Phase 1 clinical study of R-107 in healthy middle-aged volunteers in order to establish that the drug is safe and well tolerated. This study is intended as a prelude to a definitive large animal investigation to prove the safety and efficacy of R-107 in a clinically relevant model of CILI."