I think Leo will also apply for the Breakthrough Therapy designation. He mentioned it two years ago.

"Given the limited treatment options, devastating effects, and small patient population, Cellceutix believes that retinoblastoma would make an excellent candidate for a phase 2/3 trial once our present phase 1 trial is completed. It would qualify for a number of FDA programs (Orphan, Fast Track and Breakthrough) that can exponentially shrink development time, should clinical data support the current research."

http://cellceutix.com/cellceutix-plans-for-fu...akzQf.dpbs