NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

ARGS may have some evidence that a tail exists, but that trial would virtually certainly have failed if run to the planned completion.

A) Even in the 1st 1/3 subset they pull out the HR was only .88, that would not have been stat sig at the final.

B) The overall trial showed no tail. Flip down to page 28 of
Flippers linked chart , and you will see the tail for vaccine is lower than the tail for SOC.

C) The relative benefit in that 1st 1/3 subset was driven by the control arm doing worse, not the vaccine arm doing better. That makes it look much more like a random fluke than a real effect.

D) Through 75% of final events, the vaccine arm was doing worse by almost 5 months. That is a huge amount to make up.

We will possibly see the 290 event follow up data, or we may not. But it is not going to impress anybody.

As far as NWBO:

Nobody (I know of) has said the trial should have been stopped at 248 PFS. What is normal, is to unblind and release the primary data (and possibly immature OS data). Continue to follow the trial and release OS when that hits 233.

The defined PFS endpoint is at 248 events, that does not change. It is common to get a few extra events, as nobody can perfectly cut the data. But intentionally gathering more events for perhaps a year is moving the endpoint. So they are not helping the primary endpoint of the trial by maintaining the blind.

The only benefit of maintaining the blind is that they have slightly higher quality data on the OS secondary.