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    ===FDA Approval Timeline===

    ****Achieved to date...****

    1. CVac™ commenced research in 1996.

    2. Phase I trials commenced in 2001. Trails conducted on 14 patients with a variety of malignant tumours

    3. Phase II trials completed in 2007. Trials conducted on 21 patients with elevated CA125 levels (a key biomarker for disease activity)

    4. FDA pre-Investigational New Drug Application (preIND) meeting request complete August 2008. A PreIND meeting is a key milestone in FDA approval process

    5. FDA pre-Investigational New Drug Application (preIND) meeting, successfully completed - October 2008

    ***Upcoming...***

    1. Commence US FDA IND application for CVac™ - May 2009

    2. US FDA grant of Investigational New Drug Application (IND) for CVac™ ovarian cancer treatment - mid-2009. Confirms data, manufacturing and statistics all to FDA standards

    3. Pivotal Clinical Trial to commence – mid-2009. Trial to be conducted on total of 340 patients(approx) in 3 tranches

    4. FDA grant of Biological Licence Authority (BLA). BLA allows company to commence charging for use of Cvac™

    5. Full commercialisation of Cvac™. Licensing or sale to pharmaceutical/drug major
 
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