CST castile resources ltd

progress on fda approval

  1. 4,086 Posts.
    ASX ANNOUNCEMENT

    CELLESTIS LIMITED (CST)

    8 OCTOBER 2004

    Progress on FDA Approval

    Previous statements by the Company have indicated that a response for Federal

    Drug Administration (FDA) approval of QuantiFERON-TB Gold may have been

    expected by October, 2004. Consequently the Company is updating the

    shareholders on the FDA situation.

    At this time the Company has answered all questions posed to date by the FDA and

    we have no outstanding queries. These queries from the FDA have included

    questions on clinical trials and suggested modifications to our Product literature,

    which provide test use instructions, indications for use, and clinical information. All

    FDA questions and suggestions have been answered or incorporated in Company

    literature. We are advised to expect further communication from the FDA within the

    next two weeks.

 
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