In late 2005, an FDA official told me that all cell-based cancer vaccines will be evaluated by CBER with possible collaboration from CDER OO. This was forwarded to DM although he might have known that already.
Given the current structure of CBER, my guess for the chain of decision will start with Dr Raj Puri of the Tumor Vaccines Division and his boss, Dr. Celia Witten, Director of OCTGT. The outside panel, if convened, will likely be headed by Dr. Mule'. It's interesting to note that all three people were at the Provost's CD54 presentation. Judging by the questions and discussions in that meeting, the data were well received by the attending experts. Some of them will likely end up on the review panel.
In addition, Puri and Mule' were at the 1998 meeting where Dr. Urdal presented the Dendreon's antigen cassette process and the possibility of using CD54 for measuring potency. So if my guess is right, the BLA will be reviewed by people who are fairly familiar with what Dendreon has been up to from its inception. They should be able to give a fair assessment of the data knowing all the issues with a cell-based therapeutic such as variation between patients, delayed immune ramp-up, etc.
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