Biotech Values

[iwfal]

I'm not trying to be pedantic, but we either have standards or we don't. It is not DNDN's fault in any way, but merely an FDA issue. If this BLA gets approved, the standards are out the window imo.

Sturm und drang. This is clearly not true - I can cite multiple examples of drugs that didn't hit endpoints but did hit survival and were approved. And examples of just one trial being stat sig and being approved. And other trials that have been given the benefit of the doubt because of lessened side effects.

Agreed that this is a combination of all three and thus there is no exact precident. But it is a strange thing to say that somehow this signals the end of the FDA world. (I agree that since it is a complicated issue that companies will, per Dew cynicism, use to create an excuse for filing.)

From previous conversations with you I suspect you would take Provenge (on a risk/reward basis) if you had the disease at that stage. Given your doubting nature (no slam intended), this is pretty strong endorsement.