Has there been a case (I'm sure there are), (and this is slightly off the original topic), where a drug has been put in an "Expanded Access" trial (I assume you know FDAs definition of expanded access), and the original trial has failed efficacy study?
Absolutely. Most management teams I've spoken with who are candid about this say they believe it means more than half enrolled. The teams I would consider "excellent" try to have the trial almost completely enrolled or close to it.
It's worth repeating again that Pazdur has no statutory authority in this area. Legislative intent, in fact, argues directly against this desire. But people have learned not to cross him or he'll tie up your drug in limbo until he gets what he wants anyway.
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