Replies to post #805945 on NorthWest Biotherapeutics Inc (NWBO)

[seekinganswers]

"Its absence implies"
What "absence"???? Are you saying NWBO did not get a letter????
Julian beach already mentioned "major objections" and "precluded form Approval" at MHRA back in the March 18th meeting, when he also said there was NO backlog!
The formal rejection or withdrawal of the MAA is a material event. Not an appeal request, and subsequent appeal, which kicks the can 6 months further down the road.

[Gus1212]

Simple Question - Been here for over 10yrs but

Forget that question I just Deleted on this post.
If a letter was sent - the meeting would of been totally different


Don 't Make Me Leak! hello Alice

[flipper44]

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)."