Replies to post #44912 on Biotech Values

[gofishmarko]

>> You seem to be trying really, really hard to avoid thinking about this. <<

I've expressed the opinion that there appears to be no easy way for the FDA to do what I think should be done , in this and similar cases. As I said before , they may need some new rules in the rulebook.

In this case , I think they have all the leverage they need with DNDN to assure completion of 02B , since DNDN will be going to them for label expansions , new indications , etc. They don't need a legal hammer. If 02B fails they will deal with it.

Again , though , the comparison with FDA action on surrogate approvals would show that the outcome with Provenge could not possibly be worse that what routinely occurs now : no confirmatory trial completion ten years after approval , confirmatory trials that are enrolling a dozen patients a year , failed confirmatory trials , etc.