Replies to post #750239 on NorthWest Biotherapeutics Inc (NWBO)

[FeMike]

What do you make of the numerous reports that inspections were just wrapped at the end of January and therefore the 2nd CHM meeting was still pending as of then?

[meirluc]

Excellent analysis Tunnel. However, if the 3 posters on this MB
were right and the last inspection was only completed at the very
end of January, wouldn't our MAA application have its second CHM review
no earlier than February 27-28 and if so, we may receive the approval
only in late March or even in April-May (1-3 months after the second
CHM)?

[KRISGO]

Whenever I see your message, it gets me excited to read it—it's almost like the company's PR to me!😃

[dennisdave]

- If DCVax-L had its second CHM meeting 6 months after its first meeting (which to me seems likely, given the consistency of the timing over the past 2 years), then that meeting occurred on 12/19/24. That would mean that, as of today (2/19/25) we are 62 days past the second meeting

Nice theory but thats most probably not what happened since the inspection went on until in January and new inspections are unlikely after the second CHM meeting.

[RobotDroid]

Same old BS that news is coming 'soon'. It aint as long as this clown crew of inept mute nonmanagement is in place.

[Red_Right_Hand]

TVOP

How many data points was this? Can you share a histogram?

- After adding in this new information, I looked back through the data to check for patterns in duration from second CHM to approval. Of medicines where we have dates for CHM meeting 1, CHM meeting 2, and approval, there are two main clusters – one where approval came roughly 3 weeks after the second meeting, and one where approval came roughly 3 months after the second meeting.

[Baxers]

Tunnelvision, I was wondering if you could share your data on the patterns of CHM meetings to Approval date timings that you found last year. I have conducted similar research and I have not managed to find your 3 month cluster. There are a number of outliers with similar timings around 80-100 days but all those that I have found were under a very different (old) reliance pathway than DCVax-L (ECDRP) and therefore I do not think they are worth any due consideration/ comparison.

Furthermore, I'm sure folk here would appreciated your take on the present situation given we are now fairly certain of the 2nd CHM meeting date.

Thanks in advance!