Your Point #4 is right on target and extremely relevant for any advisory panel, IMO. Have you discussed Point #4 with anyone at the company?
"4. The comments of Dr. Charles Drake of John Hopkins, IMO, are particularly noteworthy. They are the first that I've heard or read discussing the issue that the level of regulatory T cells in prostate tissue in AIPC, capable of rendering attacking CD8 T cells anergic, is 3 times the level in normal tissue. That would go a long way towards answering the NCI's oft repeated critique of all therapeutic cancer vaccines as applied to Provenge in AIPC: "If there are no objective tumor responses or complete remissions early on following therapy that would indicate cytotoxicity, how can a vaccine that doesn't kill cancer cells extend survival?". IMO, the primary reason lies in the ability of memory T cells primed by CD54 expressing dAPC's to home to secondary lymphoid tissues, blocking metastases to visceral organs and killing cancer cells unprotected by elevated levels of regulatory T cells. When asked by the CBER Advisory Committee in February why CD54 was chosen as a potency marker for Provenge and why it should be correlated with long term survival, DNDN's Dr. Provost replied in a self deprecating manner that perhaps DNDN was just lucky. The next time that question is asked, there should be more thought, supporting data and analysis offered in response. JMHO."
