Innovation Pharmaceuticals Inc (IPIX)

[BonelessCat]

If Brilacidin is no longer phase 2, and now approved for phase 3, please tell us how you would describe a phase 3 ready drug? It certainly isn’t phase 0, 1 or 2.

Brilacidin OM and Brilacidin ABSSI are two different drugs, the first administered orally the second administered by injection. Only the active ingredient is the same. Two applications, two unrelated diseases, two treatments, two deliveries, two separate sets of preclinical and clinical data and testing equals two drugs. If they were the same drug then the FDA would only ask for a bridge study and not a new INDA (investigational new drug application).