Health Boards
Wed-13-06-2012, 19:57 PM
Cellceutix is extremely pleased to announce that the FDA has informed the Company that a 505(b)(2) application would be an acceptable approach for Prurisol™.
"It was a very productive meeting with the FDA providing us with valuable advice about advancing Prurisol™ down the regulatory pathway," commented Cellceutix CEO Leo Ehrlich. "Now we will begin the preparatory work necessary for a Phase 2 clinical trial application for Prurisol™ based upon the FDA guidance. The recent activity of Steifel Labs, a GlaxoSmithKline company, spending approximately $350 million to acquire rights to skin treatment drugs still in development from Welichem Biotech and Basilea Pharmaceutica demonstrates how valuable and in high demand new dermatological drugs are right now. This is a very exciting time for Cellceutix and its shareholders as we transition from pre-clinical to clinical with drugs that have incredible potential."
"It was a very productive meeting with the FDA providing us with valuable advice about advancing Prurisol™ down the regulatory pathway," commented Cellceutix CEO Leo Ehrlich. "Now we will begin the preparatory work necessary for a Phase 2 clinical trial application for Prurisol™ based upon the FDA guidance. The recent activity of Steifel Labs, a GlaxoSmithKline company, spending approximately $350 million to acquire rights to skin treatment drugs still in development from Welichem Biotech and Basilea Pharmaceutica demonstrates how valuable and in high demand new dermatological drugs are right now. This is a very exciting time for Cellceutix and its shareholders as we transition from pre-clinical to clinical with drugs that have incredible potential."
