Thanks, but no thanks. This tactic by INVESTORS is probably not going to do any good, and smacks of financial self-interest. We made our play already, prior to the decision, and even provided the PCa advocacy groups with some factual background on Provenge, and on Scher and Hussain's prior statements that contradicted their actions regarding Provenge. I personally called a number of Congressional offices and PCa advocates in April. The other side has bigger guns (especially Pazdur and Fleming), and the philosophy of the FDA is not going to change. There is currently widespread support on Capitol Hill for reining in Big Pharma and Big Bio due to drug safety issues. Even though this has nothing to do with Provenge, Capitol Hill will lumped it in together with the drug safety issue and the renewal of the PDUFA. As much as I hate to say it, FDA reversal is not going to happen without stat sig survival data from 9902B. Hopefully this happens at the interim look next year.
