Replies to post #5461 on NorthWest Biotherapeutics Inc (NWBO)

[hodge14]

"How do independent monitors analyze patient scans for safety but not efficacy? Impossible."

Can someone explain this statement to me???? For someone who has dealt with doctors reading over scan results, there is absolutely NO correlation between a scan result and the safety of the treatment a patient is undergoing.

Safety only deals with the side effects of the treatment (adverse events, etc) and provides zero insight into PFS.

What am I missing here? Does he really think that looking over a scan tells the DMC how a patient feels?

[DrChuck]

Can anyone walk me through the "math" AF supposedly worked out on the back of the figurative envelope for Newlink? It's not "adding up". He seems to be making a lot of unspecified assumptions.

In January, NewLink told investors that the median overall survival for all patients in the study -- both arms -- was 25 months. It's now March, so let's assume the blended median overall survival is 27 months.

NewLink says the phase III study was designed with the assumption that pancreatic cancer patients enrolled into the control arm of the study would have a median overall survival of 17 months.

If that's true, then it suggests median overall survival for HAP-treated patients should be around 37 months, or more than double the control arm and enough to stop the study early for positive efficacy.

Well, that didn't happen, so NewLink's assumption about the median overall survival of pancreatic cancer patients must be wrong.

Using more conservative assumptions doesn't help NewLink either. Let's say pancreatic cancer patients in the control arm should live about 20 months. Using the same blended median 27-month overall survival, this would imply HAP median overall survival of 34 months, or a 70% improvement.

Again, the study should be stopped early for positive efficacy. It wasn't.