NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

They can toss in whatever data they want.

For an approval it is virtually meaningless. When (years ago) the patient was adjucated as having progressed the treatment changed. This makes a muck of things.

The main way to determine psPD is to look at following scans over the next few months. But how do you tell the difference between psPD and true progression that was reversed by the new treatment? You really can not.

There are some new imaging methods that can help, but these scans are years old. No time travel allowed. The tech needed was unlikely to be used much back then.

Consider the following patients:

. Progression seen. Patient starts on crossover dose of -L. Shrinkage seen
. Progression seen. Patient tries Avistin. Shrinkage seen. Tumor growth restarts in 4 months
. Progression seen. Patient switches to experimental drug X
. Progression seen. Patient hit by bus and no future scan

Was the first case psPD or did -L cause the response?
Was the second psPD that only lasted 4 months, or Avistin's pseudo response issue?
Was the third due to a totally unknown effect of experimental drug X
Was the fourth case psPD? how could you know?

In addition, once a patient failed to cross (about 1/3) they are off trial except for phone call follow up. This makes and data collection of scans questionable.