Isotechnika Pharma Inc IPHAF

RE: Fast track re: LUX

[snrkid]

Stockhouse doesn't seem to allow pasting.

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 and
Drug Administration (FDA) of the United States granted fast track designation
for 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 the
development and review of ISA247. The process could be facilitated through
meetings and other correspondence with the FDA reviewers, consideration for
priority review, and the ability to submit portions of the New Drug
Application (NDA) early for review as part of a "rolling" submission.
"Thanks to the FDA's approval for Fast-Track designation, we have the
potential to more rapidly deliver to patients a much needed drug for uveitis,"
comments Ulrich Grau, PhD, president and chief executive officer of Lux
Biosciences. "If successful, LX211 (referred to as ISA247 by Isotechnika)
would be the first thoroughly tested and approved steroid-sparing therapy for
the treatment of uveitis."

hope this works......