NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

You need to read the May 2012 PR on upgrade to a phase III trial. You need to look at the historical changes to the trial over the years on clinical trials.gov. There was other info that came and went.
(You're getting angry at the wrong people AKA.)

From my memory -- not exact:

Each interim the DMC is supposed to do a statistical analysis of

1. The Primary Group minus the 33 carry over.

2. The 33 carry over.

3. The primary group plus the 33 carry over.

If and only if they reach Statistical Significance on #3 above, the DMC will then:

4. Separately Statistically Analyze the tertiary pseudo-progression group.

5. Separately Statistically analyze #3 plus #4.


Only # 3 will be used to determine the actual primary and secondary endpoint analysis.

There are/will be 312 in the phase 3 trial (unless this goal is changed).

240 ultimate enrollment in the primary group -- to determine the primary and secondary endpoint.

72 ultimate enrollment in the secondary group -- to determine the tertiary endpoint (and give further scientific background to help determine possible application expansion for other patients).