Introgen to appeal FDA's refuse to file decision on Advexin BLA
Introgen Therapeutics says that its US Biologics License Application for Advexin (p53 tumor suppressor therapy) for the treatment of recurrent, refractory squamous cell carcinoma of the head and neck, submitted on June 30, was not sufficiently complete and would not be filed at this time. The company intends to appeal this "refuse to file" decision and is reviewing the various options available to it. Earlier this month, Introgen and its subsidiary Gendux Molecular announced that the European Medicines Agency (EMEA) accepted for review the European marketing application for Advexin.
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