NorthWest Biotherapeutics Inc (NWBO)

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Specifically,

Here is the exact regulatory path for a positive recommendation that includes a 28-day window:

1. The Regulatory Link

The statutory power is The Human Medicines Regulations 2012, Schedule 11.

While Paragraph 1 covers "Refusal," Paragraph 5 and Paragraph 6 cover the scenario where the CHM is ready to approve but has "provisional" conditions or changes to your application.

2. The Positive Approval Wording
Under the MHRA National Assessment Procedure (2025 Standards), if the CHM meeting is positive, the letter issued is an "Advice Letter."

The exact wording for a positive outcome at Day 150/170 is:

"The Commission [CHM] has advised that a Marketing Authorisation may be granted, provided that the following minor outstanding issues are resolved and the conditions of the grant are accepted by the applicant."

The "28-Day" Trigger:

"The applicant will have 28 days from the date of this notification to respond to the minor outstanding issues or to provide the final version of the product information (SmPC, PIL, and labeling)."