I don't believe NWBT's results are from a randomized trial, as it's an orphan indication. Their results are therefore being compared to historical data. The Provenge non-randomized Phase II results were extremely impressive for progression in AIPC when also compared to historical data. One of my biggest beefs re DNDN mgmt is that they have yet to run a Neuvenge trial in HER2/neu+ ovarian cancer, which would be an orphan indication and could theoretically gain approval via a single-arm trial.
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