NorthWest Biotherapeutics Inc (NWBO)

[MI Dendream]

Senti, The trial was enrolling about 20-30 per month at prior to the halt in new screening.

What makes the most sense to me is that only 31-32 entered the trial after the halt and all of these patients were ‘randomized’ to treatment without the company’s knowledge. Since this maneuver actually weakens the study’s power, rather substantially, I contend that a regulator would only do so with the knowledge that the primary endpoint was a slam dunk. The DSM and regulators can be unblinded to the data while the company, investigators, patients and CROs are not, thus maintainIng the blind.

It could be that the DSM having been unblinded to either progressions or deaths or both reported as SAEs Saw a clear distinction between treatment and placebo. After the halt, the company imdicated that it provided more data to a regulator. I believe that the unblinded regulator required the final 31-32 patients be put on drug because doing otherwise would be unethical.