Replies to post #710480 on NorthWest Biotherapeutics Inc (NWBO)

[VikingInvest]

I agree with those timeframes. We do need to remember that those are just guidelines and not set in stone. We are dealing with a government agency and NWBO. I am not saying that they will be late as they could also get it done ahead of time.

Just my opinion.

Good luck to all long term shareholders.

[ROS-CH]

Not unrealistic, but I think you did not consider two things :
- Inspections can be rescheduled - particularyly then, when
- NWBO started the preparations. Knowing their snailpace with 'things',
rescheduling is more likely than not.
(You are allowed to call me a big sceptic)

[RobotDroid]

It was January. Man people are dense.

[learningcurve2020]

Point #1 -The "Review" refers to inspection of the trial sites not the CDMO facilities. They did not specify.

Point #2 -They did not specify whether it was MHRA or themselves who have scheduled.

I'm wondering after all this time what possible input could LP and LG have to offer their "Team of Consultants"?


>>Meanwhile, we are continuing to focus on working with our teams of consultants on activities related to the review by the Medicines and Healthcare Products Regulatory Agency (MHRA) of our Marketing Authorization Application (MAA) in the UK, including preparations for inspections by the MHRA that are scheduled to take place in both the US and UK.

[attilathehunt]

Hypothesis:

March 7th Validation Date.....January 24th

Phase 1: 80 day assessment begins March 7th and ends May 26th....April 13th

RFI: 60 day clock-off begins May 26th and ends July 25th (one week ago)...June12th

**Inspections are scheduled** (hey we just found this out).

Phase 2: 70 day assessment begins July 25th and ends October 3rd (with approval)...Aug 21st

Just saying, it makes sense.

[scotty3371]

That's is correct. March was validation date not January.

[hyperopia]

That doesn’t make sense to me. The MHRA began publishing the average time to validation for new MAAs in April, and according to the data that month, the average time to validation was 7 days. The latest update from the MHRA indicates the average time to validation has been cut to 5 days.

Granted, Northwest Bio’s application was submitted right before the Christmas and New Year’s holidays, when many government agency employees are given a couple of weeks off, so it seems that the application wasn’t validated as quickly as it normally would have been, but it doesn’t make sense to me that it took anywhere near 78 days for validation and the start of assessment.

On a related side note:
Why would Linda and Les both think that Northwest Bio’s application has received priority review from the MHRA, and is being assessed under the 150-day accelerated pathway?

Because Linda and Les are in the perfect position to know. They have been overseeing the responses to the MHRA’s questions about the application, they understand how each phase of the assessment works, and approximately where the MHRA is in the review process. And more importantly . . . they know this because the MHRA recently began providing applicants with the ability to track a marketing application through the review process:

RegulatoryConnect

The Medicines and Healthcare Regulatory Agency have launched RegulatoryConnect, a service that provides the capability to track applications and view live authorisation details.
From:
Medicines and Healthcare products Regulatory Agency
Published
25 March 2024
Last updated
15 April 2024 — See all updates

The RegulatoryConnect portal will provide greater transparency and visibility for regulatory assessments to industry. The functionality will let industry users log in using existing MHRA submission credentials and access RegulatoryConnect, where they will be able to:

* Use the Applications page to track the status of an application and see which stage it is at.

* Use the Current Granted View page to view live authorisation details, including status, key data and documents held against existing licences.

These services are available to those making applications to the MHRA on behalf of their organisation as an administrator or user.

Future functionality and features will be added to RegulatoryConnect later in the year, including the ability to submit applications and variations to the MHRA through the service.

https://www.gov.uk/guidance/regulatoryconnect


RegulatoryConnect guidance

Navigating the RegulatoryConnect portal
Published March 2024
https://assets.publishing.service.gov.uk/media/65fc55b8a6c0f70011ef91db/RegulatoryConnect_-_Navigating_the_RegulatoryConnect_portal.pdf


Understanding application statuses
Published March 2024
https://assets.publishing.service.gov.uk/media/65fc55b865ca2f00117da815/RegulatoryConnect_-_Understanding_application_statuses.pdf