Pivotal phase III will require at least 300 patients and will...

Pivotal phase III will require at least 300 patients and will take 2 years+ to allow for recruitment etc...therefore late 2010 means that should be completed by mid 2013 and marketing approval if all goes will then be mid/late 2014

The FDA usually require some trial centres to be in the US in any pivotal phase III study so I'm a bit surprised that they only plan a trial in Europe under EMEA

With patent expiry in 2014 orphan drug status is key in trying to extend the monopoly market period, without it CVAC is dead