blackjack
There is now a clear pathway to Phase III and regulatory approval. CVAC Phase IIb trial commenced in mid-2010 and it is now merging into an 800-patient Phase III, to be conducted mainly in Europe from mid-2011.
Ordinarily a drug or medical device requires two Phase III trials before it can apply for FDA approval. However PRR guidance from the FDA is that CVac IIb and III trials will be sufficient for this product. We expect this Phase III to help put CVac on the market by 2014 or 2015.
http://www.primabiomed.com.au/investor/analyst_reports_pdf/Prima20110519.pdf
reply from martin rogers re dubai release, page-38
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