NorthWest Biotherapeutics Inc (NWBO)

[CherryTree1]

The Truth about the initial primary checkpoint
. . . and from Seeking Alpha which would not be hailed as a friend and pumper of NWBO.
https://seekingalpha.com/article/4513591-northwest-bio-buy-again-wait-for-regulatory-process

Pseudoprogression is a common enough phenomenon in immune therapies, and diagnostic techniques - see here - have been studied to try and distinguish a pseudoprogression from a real progression. Outside of diagnostic techniques, a good way, where possible, is to ignore progression altogether and go with an OS endpoint - exactly what NWBO has done.

In plainspeak, when you take an immunotherapy medicine, the drug activity itself may cause the tumor to get inflamed, basically acting as if disease has progressed. However, if the progression then subsides, a simple PFS endpoint is not going to be able to measure it. What is then needed is overall survival, which can tell us whether the progression was real - causing death, for instance - or it was fake, subsiding later to produce a complete or partial response, and ultimately improving overall survival.

This is exactly what happened with the DCVax-L trial. Before data was unblinded, they changed the PFS endpoint to a much more robust OS endpoint, and they saw success - so if bears are telling you otherwise, be sure you know what is happening.

Dr Linda Liau, the originator of the DCVax-L therapy, has consistently been aware of, and tried to avoid, pseudoprogression from the trial.

Again and again and again
Before data was unblinded, they changed the PFS endpoint to a much more robust OS endpoint,

Before data was unblinded, they changed the PFS endpoint to a much more robust OS endpoint,

Before data was unblinded, they changed the PFS endpoint to a much more robust OS endpoint,

which is perfectly acceptable so long as it is done before unblinding. When it is all said and done Overall Survival and safety are the only things that really matter.