Subject: FDA Holds Up Imreg's Application On Anti-AIDS Compound
Date: Published: 11/30/88 32 lines
Source:  Wall Street Journal.  Copyright Dow Jones & Co. Inc. 

    Business Brief -- Imreg Inc.:  
    FDA Holds Up Application
    On Anti-AIDS Compound

    Imreg Inc. said the U. S. Food and Drug Administration has
 placed on "clinical hold" the biomedical concern's
 application for investigational drug status for its compound
 to combat the AIDS virus.
    As previously reported, Imreg's executives came under
 sharp criticism from FDA staff two weeks ago during a public
 hearing before an FDA advisory committee of outside medical
 experts reviewing Imreg's clinical trials of its compound.
 The advisory committee withheld its recommendation pending
 response by Imreg to the FDA's inquiries and analysis of the
 clinical trials.
    New Orleans-based Imreg said the FDA's "clinical hold" was
 placed on the application pending Imreg's presentation of
 additional data to the FDA and the advisory committee.
 Investigational drug status is given if a drug has been
 proven effective and allows distribution to patients even
 before being approved for commercial marketing.
    Imreg stock rose 75 cents yesterday to close at $4.375 in
 national over-the-counter trading.

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