MI-100 regulatory update

Makindus said FDA granted Orphan Drug designation for MI-100 to treat Stargardt's disease. The company will begin Phase III testing for the product early next year. Makindus is developing MI-100 under section 505(b)(2) of the Food, Drug and Cosmetic Act, which allows sponsors to reference data on safety and efficacy from the scientific literature or from previously approved products. ...