Ppl who have been claiming that comparison needs to show distinction, what's your answer to this??
As has been pointed out numerous times by "us".
You can you a single arm trial if the endpoint is response rate (the cancer going away, CR or at least 25% shrinking, PR ). If the cancer goes away or shrinks, the drug must be effective because this does not happen naturally.
The FDA has approved drugs based on single arm response rate data in the past.
"We" know this and have stated it.
But this does not work for either survival or PFS in the -L trial. You can not say that a person who lives 2 years indicates the drug has worked because people live that long w/o DCVax-L. And furthermore, the endpoint is already designed with comps in place.
And it does not work for Direct because Direct looks to have no to little responders. If the response rate is near zero, you can not get it approved based on that. Should be obvious.
On a more general point. Dendritic Cell vaccines of all forms are better at preventing spread than killing in bulk. That makes response rate a poor metric.
Market Data 
Markets 
AI
