NorthWest Biotherapeutics Inc (NWBO)

[foxhound02]

This is the Flipper argument and it is not consistent with the facts. The PR stated the issue had to do with questions about enrollment "criteria" -- remember sniffles etc. It do not say there was simply a temporary hold. First, if there were a temporary hold because they were reviewing data for AA, the PR would not have been so specific regarding the reason. Further, FDA would be reviewing a massive amount of docs on every aspect of the study. So, why point to patient characteristics as the reason. Makes no sense as I told Flipper. The simplest explanations are:

1. The DMC noted irregularities in the application of recruitment criteria at one or more sites. This triggered an alert to FDA and a hold pending review. Or,

2. The was an adverse event that triggered a review of enrollment criteria.

I will not be posting for a while, so that it will be easy to find this post when I have to remind you that I was correct.