Replies to post #41106 on NorthWest Biotherapeutics Inc (NWBO)

[Doc x 4]

Dan what would be an example of a ph 4 , such as number of enrolled etc? Thanx

[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.

[Smokey21]

I initially was not thinking this was a stop for efficacy. But, based on the Information arm data presented this week, it's my belief that the PFS data is too good to deny and OS data has also had time to mature on the earlier patients. All of this I believe points to an indisputable efficacy and safety profile that would warrant accelerated approval.

This, combined with the expansion plans launched at Cognate makes me believe we will hear something very positive soon. I think Cognate had those plans on the shelf just waiting for the results of the IA. One they decided to apply for AA, they quietly launched their expansion plans. But, those on this board who are very resourceful discovered that news, despite no announcement from NWBO on that front.

I think this is also why we haven't heard anything on financing yet. All of the ducks seem to be lining up nicely in a row.

[Stillwell888]

Hope you are right as I am long but my understanding is that the halt emanates from German regulators and is not about efficacy or safety but so sort of bureaucratic snafu.