Dendreon Corp fka DNDNQ

[ocyanblue]

I wondered if that harshness was a kneejerk reaction after the relatively soft review of the Provenge BLA and the ensuing mess. Pazdur and CDER were bent on a "we'll show you how it's done here" kind of thing after forcing the Provenge CRL right before their own CDER AC meeting. The published OrBec data actually looked decent so the later extension of the review date for OrBec might have been a small sign of remorse on Pazdur's part. Not saying that this is a strong motivation, but given the ongoing publicity and lawsuits against the FDA, a factor to consider is that a reversal of the negative AC recommendation for OrBec would serve as an example that absolute approval authority for any cancer drug remains with him and the FDA.