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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