NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

FDA is asking CVM to run a confirmatory trial in a tight criterion patient population. This means FDA will easily approve DcVaxL.

So let me get this right,

The FDA has called BS on CVM's attempt to paint some failed trial as sufficient for approval and sayign CVM needs to run a proper trial and show positive results from that to get an approval.

And somehow that means the DCVax-L failed trial is worthy of approval?

There is a reason why Dr Liau says she hopes patients can access -L via Right-to-Try or such while waiting for trials to prove or disprove efficacy.