NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

If they had a futility hold, I doubt very much the FDA would have approved their providing DCVax-L on a humanitarian basis, cross-border (in the jurisdiction of another regulatory body, no less, with even stricter rules around making claims and disclosures), no less, collecting hundreds of thousands of dollars from the patients, without a complete disclosure. I doubt that is even possible.

Why would the FDA halt compassionate access just because a trial fails? Certainly they allow patients on trials to continue. And certainly if the drug is already approved in other indications they will not stop off label use.

People miss the simple fact that a trial failing does not imply the drug does not work. Plenty of blockbuster drugs fail some trials.

Cross boarder? The FDA has no say.

Cost? That is a great point. The FDA certainly does insist that companies can only charge direct costs in compassionate use cases. Is it really cheap to manufacture?