NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

The vanguard cohort

First 38 patients enrolled and were not tested for mgmt
24 (almost 2/3) of these patients were in the placebo non-crossover arm.

14 (about 1/3) of these patients were in the original DCVax-l arm.

Yes, you read right, there were nearly double the amount of placebo control patients to treatment patients in the vanguard cohort.

The blended survival at three years was 15.7% (Aka: 6 out of the 38 lived to three years)

The non-crossover cohort.
35 patients.
24 of these patients were from the vanguard cohort above with no mgmt status.
The remaining nine patients were methylated mgmt.

The main trial without the first 38 vanguard patients

Excluding the first Vanguard patients that were first enrolled, the remaining patients were:

284 = received DCVax-l (Aka: 97%)
9 = mgmt methylated non-cross over placebos (Aka: 3%)

Conclusions:

Clearly after the vanguard group was enrolled and observed, crossover became a high priority.

With only six out of 38 surviving three years, the vanguard group was not responsible for strengthening results in the overall trial.

With 2/3 of the vanguard group being placebo non-crossover, it is highly unlikely the vanguard group improved the overall control group response.

Excluding the first 38 vanguard patients from the trial, only 3% did not crossover in the remaining (n= 293) trial, essentially making this a one arm trial.

Dropping the vanguard group from the trial results would give a much clearer ECA comparison.

Imo