Isotechnika Pharma Inc IPHAF

RE: RE: Rolling submission for approval

[snrkid]

    Lux was granted "fast track status" in 2007, therefore all submissions and discussions with FDA authorities are part of NDA proces.  Do they need separate nda application for approval besides submiting data as it comes available?  Propably not since fast track proces is geared towards marketing approval. 

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News Releases

Isotechnika's lead drug, ISA247, receives fast track designation from FDA for the treatment of uveitis

    EDMONTON, Aug. 7 /CNW/ - Isotechnika announced today that the Food andDrug Administration (FDA) of the United States granted fast track designationfor the Company's lead drug, ISA247 under section 506 of the Federal Food,Drug and Cosmetic Act. The FDA based its decision on the following reasons:    -   ISA247 is intended for the treatment of a serious or life-threatening        condition, namely non-infectious posterior, intermediate and        panuveitis, and    -   ISA247 demonstrates the potential to address medical needs unmet by        available treatments for non-infectious posterior, intermediate and        panuveitis.    Fast Track designation will provide various means to expedite thedevelopment and review of ISA247. The process could be facilitated throughmeetings and other correspondence with the FDA reviewers, consideration forpriority review, and the ability to submit portions of the New DrugApplication (NDA) early for review as part of a "rolling" submission.    "Thanks to the FDA's approval for Fast-Track designation, we have thepotential to more rapidly deliver to patients a much needed drug for uveitis,"comments Ulrich Grau, PhD, president and chief executive officer of LuxBiosciences. "If successful, LX211 (referred to as ISA247 by Isotechnika)would be the first thoroughly tested and approved steroid-sparing therapy forthe treatment of uveitis."    "We are extremely excited that Lux received Fast-Track designation forISA247 for the treatment of uveitis," stated Dr. Randall Yatscoff,Isotechnika's president & chief executive officer. "We are continuallyencouraged by the broad potential use of ISA247 in transplantation, psoriasis,and uveitis."