NorthWest Biotherapeutics Inc (NWBO)

[foxhound02]

It seems that folks might be confusing the role of a DMC committee and an FDA advisory committee. It is the company that would have built into the trial design various considerations, most importantly the size and powering of the study. Linda has spoke to the details of how the trial is designed and powered. At this point, the DMC will crunch the numbers. Either the stats say stop or continue. When a company submits a drug for approval to the FDA, there is an advisory committee that meets and gives its recommendation. Recall, for Dendreon the study met most endpoints and they voted overwhelmingly for approval. The FDA usually follows the advisory vote, but they do not have to and in the case of Provenge, they shot it down on the first submission. They wanted to see how the data looked for a second trial that was ongoing at the time of submission. By the way FDA generally wants to see data for two large trials. I do not think this would be the case for dvax-L.