Hi Jeff! My take is same as yours! They are brilli
Post# of 72440
Hi Jeff! My take is same as yours! They are brilliantly maneuvering to get this drug on the most rapid approval path possible. The current phase one trial is going well. They are counting on this safety trial to lead them into advanced trial for retinoblastoma which would give them orphan status with FDA.The orphan drug act has a rare pediatric disease priority review voucher incentive program. Retinoblastoma is a rare pediatric disease. They are master strategists. This will bring Kevetrin to market so much faster than most of us anticipated. I wouldn't want to be Leo's opponent in a game of chess. He's always 10 moves ahead.
"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. “While our Phase 1 clinical trial is ongoing, we are planning for future trials that are aimed directly at the latest initiatives of the Food and Drug Administration to expedite development of ‘breakthrough’ technologies to commercialization,”