NorthWest Biotherapeutics Inc (NWBO)

[MI Dendream]

LC2020, The August 2020 halt was a halt in the use of placebo, not a halt in enrollment or a halt in the study itself. Whether FDA initiated this halt or agreed to follow suit with another regulator is irrelevant. The process outlined at the time looks very much like an FDA process, but this is opinion.

If you can give a rational explanation other than the idea that the DSM called for this halt after viewing unblinded safety results which since the drug has no side effects must be the ultimate safety signal, i.e., death, that leads to such activities that have transpired ever since, I am all ears. The key word here is rational. This explanation has no flaws based on what has been seen. All others do and I am happy to crush any that you put forward.

Not one rational explanation other than DSM seeing an efficacy signal through death rate has ever been given on this board. Not one.

Many definitive diagnosis are made through exclusion of other possibilities, for example ALS. There is no test for this, but there is a way to exclude everything else.

My diagnosis here, and I am not a physician but this is not a patient, is that DSM saw a clear difference in death rate as they are unblind on death, and then called for a halt in the trial. Regulators allowed NWBO to continue on in a blind fashion, but required all Placebo to be halted. This begins one quiet period which pulls through until TLD is reported and a package is submitted. This is a regulatory quiet period, different from the one which is self-imposed currently but there is a high correlation between the two. PERIOD.

I do have a flexible mind, however, even for rodeo clowns. So have at it?