Replies to post #744067 on NorthWest Biotherapeutics Inc (NWBO)

[FeMike]

As a result, it has never even come close to being considered at a CHM meeting

So just to be clear, it’s your belief that the drug referenced in the June CHM minutes was, in fact, a different brain cancer treatment? Can you enlighten me as to which other brain cancer treatment is currently under MHRA review?

CHM minutes from June said they considered:

"a medicine indicated to treat adults with brain cancer."

[sentiment_stocks]

So why did the MHRA bother conducting all those inspections sometime after August 9? If what you suggest is true, it would be a considerable waste of money on MHRA's part to move forward with inspections in both the U.K. and the U.S. if the DCVax-L application was derailed back in February 2024, as you insist.

I think you write with a forked typewriter.

3rd Quarter 10Q - published November 12, 2024

MAA Application and Inspections. The Company has continued to work with multiple teams of expert consultants, the trial’s CRO (contract research organization) and Advent BioServices on the MAA process. The review of the application is ongoing, and inspections are being conducted in the U.K and the U.S. Each inspection involves pre-inspection requests from the inspectors for production of extensive documents and information, weeklong onsite inspections (including review of further documents, interviews of personnel, checking of facilities and procedures, etc.), and ongoing follow-up document and information requests after the onsite inspection. The inspections cover the sponsor, the CRO, the independent experts involved in the trial (such as the independent clinical database company, independent statisticians and others), selected trial site hospitals and their pharmacies, and others. As is typical, and as the Company has previously stated, the Company does not plan to make any interim announcements while its MAA is going through the regulatory process. The Company plans to announce the results when the regulatory review and decision-making is finished.
https://www.sec.gov/ix?doc=/Archives/edgar/data/1072379/000141057824001879/nwbo-20240930x10q.htm

2nd Quarter 10Q - published August 9, 2024

Preparations for Regulatory Inspections. As previously reported, preparations for regulatory inspections associated with the MAA have been a major focus of the Company’s activities this year to date, including mock inspections. Inspections by MHRA are scheduled to take place in both the U.S. and the U.K.
https://www.sec.gov/ix?doc=/Archives/edgar/data/1072379/000141057824001278/nwbo-20240630x10q.htm

Nemesis - your flurry of regular posts encouraging everyone to sell stopped on September 1, 2024. Here is that post:

Nemesis18
Re: RobotDroid post# 717371
Sunday, September 01, 2024 5:45:11 PM
Post# of 744112
I told everyone here months ago that the application had derailed, with that starting to happen from Feb.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=175020235