Isotechnika Pharma Inc IPHAF

FDA request for further data

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I think we need to remember that when Lux received fast track status back in August 2007 it was for the following reasons (directly from the news release):

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.

Further...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.


Personally, I think it is highly UNLIKELY that they will request additional data given that they have had access to data for almost three years now.  Just my opinion.