Replies to post #773163 on NorthWest Biotherapeutics Inc (NWBO)

[Red_Right_Hand]

Nonsense. If what you say is true, then please explain why MHRA publishes deadlines for MAA submission to coordinate with the next CHM meeting date. And then, if the CHM meeting date is followed 7 days later by the "1st RFI" date, who will be reviewing the applicant's response to that RFI? And if it's the CHM that is reviewing that response, when will they discuss and advise on that response and determine whether that response is sufficient, or whether a second RFI is required? At the 2d CHM meeting.

https://www.gov.uk/guidance/submission-and-assessment-timetables-for-innovative-medicines-applications

2. Deadlines for initial submissions

The MA application dossier should be submitted through the MHRA submissions portal on or before the deadline (DD/MM/YYYY) as detailed below.

Submission deadline Procedure start date* (Day 0) CHM meeting (Day 83) First RFI (Day 90)
11/04/2025 02/05/2025 24/07/2025 31/07/2025
16/05/2025 06/06/2025 28/08/2025 04/09/2025
16/06/2025 07/07/2025 28/09/2025 05/10/2025
18/07/2025 08/08/2025 30/10/2025 06/11/2025
15/08/2025 05/09/2025 27/11/2025 04/12/2025
05/09/2025 26/09/2025 18/12/2025 25/12/2025
17/10/2025 07/11/2025 29/01/2026 05/02/2026
14/11/2025 05/12/2025 26/02/2026 05/03/2026
12/12/2025 02/01/2026 26/03/2026 02/04/2026
09/01/2026 30/01/2026 23/04/2026 30/04/2026
06/02/2026 27/02/2026 21/05/2026 28/05/2026
13/03/2026 03/04/2026 25/06/2026 02/07/2026
17/04/2026 08/05/2026 30/07/2026 06/08/2026
15/05/2026 05/06/2026 27/08/2026 03/09/2026
12/06/2026 03/07/2026 24/09/2026 01/10/2026
17/07/2026 07/08/2026 29/10/2026 05/11/2026
14/08/2026 04/09/2026 26/11/2026 03/12/2026
04/09/2026 25/09/2026 17/12/2026 24/12/2026