Dendreon Corp fka DNDNQ

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These are the characteristics of the Avastin trial that may give it some advantage over Provenge:

1. Avastin+Chemo over Chemo, not drug vs. placebo.
2. Large trial, 900 patients with an out-of-the-park p value.
3. Likely doing well in various subgroup analyses.

The main problem is 3 with the Provenge trials because 9902a is a subgroup of the integrated data that fails the log-rank test. We all know about the arguments on a smaller and abruptly truncated trial, imbalances, etc. However, it remains a controversial data point. A mitigation factor is that the Cox p-values are significant in all three data sets 9901, 9902a and 9901+02a. Further, the Cox p-value of 9901+02a is significantly smaller than of the others lending credence to the assertion that 9902a supports 9901. So an enlightened statistician may look at this data favorably.

But to me, the evidence pointing toward a panel is that its possibility must have been raised in the pre-BLA meeting and communication should have been going on with the company. As the company continues to expect a panel, that likely means that they have more info about that than publicly available. The below link is the published timeline to prepare for a panel for both the FDA and the company. Note that the need to convene a trial should be identified by the FDA 9 months beforehand and communicated to the sponsor. So if a panel is expected in Feb'07, that need should have been identified since last May/June. The company may hope that one will be waived but they should be working hard on preparing for it now.

http://www.fda.gov/cder/Offices/OTC/Abbreviated_timeline_FDA_CHPA_seminar_fall_06.pdf