The fact that this pivotal trial changed its endpoint (in the middle of the trial) from survival to complete response is not reassuring. It means that they were not going to be successful in achieving significance with this endpoint.
The key question remains- will this drug ever get to market?
Interim analysis of U.S. Phase III data (1Q08) Complete enrollment of U.S. Phase III trial to treat VOD (1Q08) before was 2007 Complete enrollment of EU pediatric trial to prevent VOD (1H08) Submit file for treatment of VOD in U.S. (2H08) Submit file for pediatric prevention of VOD in EU (4Q08) US expected approval of VOD Treatment (1H09)before was 2008 EU expected approval of pediatric prevention of VOD (2H09)
so pratically they are 6 months late
With the low price they can get cheap stock options.........