Interim data was supposed to be available in June, thereabouts. A delay can mean people are living longer than anticipated or that the data was not as robust as anticipated and therefore the company is combing through the data looking for validation. I think Vical recently did the latter - as their drug trial had failed. I am hoping this is a case of the former.
The trial design does not provide for "combing through the data" and there is no futility analysis. There will only be an announcement either that the trial reached statsig at this point (222 events) in the trial, or they are continuing to 333 events. Longer wait means the patients, trial and/or control, are living longer as a group than expected OR that enrollment took longer than expected. We should see an announcement very soon regarding complete enrollment.
As of aug 2012 2nd qtr. press release the first interim trigger was first qtr. then in feb first qtr release the first interim was expected mid year . We are now mid third qtr. no trigger. This trigger is based on one thing and one thing only , the death of 222 patients there is no combing through the data.