NorthWest Biotherapeutics Inc (NWBO)

[sentiment_stocks]

If Germany felt that the placebo arm was not ethical - assuming they knew that DCVax worked (and their number explains the exact number of missing patients in the trial) - then they chose not to enroll those placebo patients in the trial.

However, those placebo patients would have had the opportunity to cross over upon progression. Additionally, those patients would have had their vaccines made.

So if this is how it happened, then how were these 17 placebo patients with vaccines made handled? Were they put into the EAP trial? Or told they couldn't enter the trial?

We remember the patient in Germany who's wife thought that he was to have been a placebo patient in the trial, but that he was unable to enter. Had he entered into the EAP and received the vaccine at once, I don't think she would have written that blog post in the manner she did, implying, as memory serves, that her husband did not receive DCVax, nor enter the trial.

So that would be a pretty bad, mean spirited decision, to my thinking anyway, if those 17 potential placebo patients were basically unable to enter the trial, nor the EAP trial, because DCVax works.

And this would have all taken place, presumably, without the company knowing it?

There are square pieces that aren't fitting into the circle holes here.

I realize, of course, to reiterate, that the numbers mathematically work out perfectly, which is bizarre. And for those who don't know what we're talking about, here it is:

The trial was supposed to enroll 348 patients.

Instead, after the screening halt, the number of patients were reduced to 331. We think there were about 31 patients who entered the trial after the screening halt as they were already in the screening pipeline (in August 2015) and their vaccines were made.

Later when the journal article came out, it revealed that there were 232 treatment patients, but only 99 control patients, equaling 331.
https://translational-medicine.biomedcentral.com/articles/10.1186/s12967-018-1507-6

However, 232 treatment patients was the correct number of patients who should have been enrolled in the trial, had it enrolled to the full amount of 348. The trial was supposed to enroll 2:1 (2 treatment to 1 control). So 348/3 = 116; thus 116 was to be the control number, and 116 x 2 or 232 of treatment patients.

So 116 supposed-to-be-control patients - 99 control = 17 patients.
and
348 - 17 = 331 (the number of patients now in the trial)

We should note that LG and DI have insisted rather profusely that this is all coincidence and that everyone was randomized as the trial had planned.