NorthWest Biotherapeutics Inc (NWBO)

[MI Dendream]

Many times I have stated here my conclusions as to the screening halt. Several others with deep experience and knowledge in this realm concur.

Some time during the Summer of 2015 the Data Safety Monitoring committee called for a study halt, but the company decides and decided to continue on with the trial. Since the reason for halt was not a safety or manufacturing issue with DCVax, FDA and other regulators allowed this, but required changes to the study design which removed placebo from the trial. (IMO this includes both patients in screening going to go on therapy AND patients in trial currently receiving placebo)

Death is always an unblinded safety event reviewed by the DSM. I have never heard one credible explanation other than that the DSM saw a clear increase in death among placebo treated patients and called for a halt. No IA needs to be performed to see efficacy on OS, but that does not mean if you stop at that point you are guaranteed approval nor does it mean you will have marketable data for commercialization which can help you gain and maintain a clinical advantage and become SOC. Thus LP, chose to march on and the rest is history.

The history of the greatest step forward in oncology since who knows what if anything.