Replies to post #44597 on Biotech Values

[exwannabe]

No, David is clearly correct.

The AA program is very exact in it's definition, allowing AA based on a drug showing effect on a surragate that has not yet clearly shown to be of clinical benfit (but obviously is believed to be of benfit).

The exact question of "can a OS benifit with less supportative data qualify for AA" was actually asked of the FDA in it's public comments period on the AA process. The FDA said NO, period.

I don't dispute the logic of the argument you and a few others make, but it has no relavency to present FDA decision making.

It's also irrelavent to Prov, it clearly gets aproved despite somewhat skimpy supportative data.

[walldiver]

DNDN -- The expansion of 9902B into Europe is a BSR idea...I think a lot could be accomplished by opening up more Canadian sites (currently only one or two Ontario sites are open), expanding into Australia, and perhaps one or two NW European countries such as Germany and the UK. The UK because of a high incidence of PC plus no language barrier, and Germany because that country seems to be fairly enthusiastic about cancer vaccines (Merck KGaA). Increase the 9902B trial size to 600 patients, halt US enrollment, and start an expanded access program for minority patients (especially African Americans), who disproportionately suffer from AIPC but were under-represented in the Provenge trials.