Replies to post #764859 on NorthWest Biotherapeutics Inc (NWBO)

[manibiotech]

Well that's the problem with complete non transparency of the process . Technically clock off period could be even longer depending on if they get another RFI used in above numbers . 

[Arby2000]

RRH: Your analysis means that all the brouhaha yesterday about the NWBO MAA being backlogged and potentially rejected by MHRA and punted to CHM was just a way to shake the trees for weak-minded holders to shed their shares.

[Red_Right_Hand]

Another way to say what I laid out below is, assuming that NW took all the clock-off days available to them to respond rather than responding early (which is unfortunately not a crazy assumption to make), then NW's MAA still has 18 clock-on days (if clock started on 1/24/24) or 61 clock-on days (if clock started 3/7/24), PLUS any remaining unused clock-off days, before NW's MAA would be considered to be 'backlogged' (i.e., beyond 210 clock-on days).

And, crazy as it may be, if the clock started on 3/7/24 and NW took all available clock-off days, then MHRA could approve tomorrow, 4/30, and MHRA would still be able to say this MAA was approved within MHRA's accelerated 150-day review process.

[j e d]

Thanks RRH. Reframed for max decision date:

Given the maximum times allotted for review & RFIs (https://www.gov.uk/guidance/national-assessment-procedure-for-medicines), here's the calc for the latest possible decision date where the MHRA can still say they reviewed within statutory time:

Validation: March 7, 2024
Initial assessment: 90 days
RFI #1: 180 days
Assessment of RFI #1: 60 days
RFI #2: 90 days
Assessment of RFI #2: 60 days

Max decision date: June 30, 2025

(Although they technically allow for a third RFI which would add up to another 3 months, and also allow for further RFI extensions in exceptional cases)

[sentiment_stocks]

In the YouTube March 18, 2025 Board Meeting, the following question is addressed to Julian Beach (Interim Executive Director Healthcare Quality and Access). Link is here.

2:40:10

So if we move onto another presubmitted question which is for Julian to answer… this one is about the publication of the information that all new license applications received since the first of September are being processed within expected time frames. The question is whether this means that the MHRA are prioritizing applications submitted after the first of September over those that may be in backlogs.

And Julian answers:

Thank you for the question. And we have covered this a bit today in board in terms of what we’re looking at but I’d like to assure that we’re not prioritizing new applications over backlog applications. So that we have written individually to all companies with outstanding applications within the backlog recently. And some of them, a small number have got major objections which do preclude approval at this stage and they're going through CHM; our commission on human medicines, and as soon as the outcome is clear from the CHM meeting those will be communicated to the respective companies. We have put in place new communication routes, so just looking at how do we communicate, and with additional resources in that vein to assure more transparent communication. And as the numbers in that backlog have significantly reduced, it’s a much more manageable way of ensuring that we have effective communication with companies.

So I find it interesting that on March 18, Julian states that there are still “companies with outstanding applications within the backlog recently”, as MHRA has written to them, and yet on March 31, 2025, they’ve somehow cleared all the backlogs?

That seems quite a stretch, as we are talking just 13 days to clear all those outstanding applications. So I’d suggest that an alternate theory is that MHRA hasn’t really completely cleared their entire backlog of outstanding applications (didn’t someone suggest some minutes from some meeting stated there will still three?).

And yet another alternative theory is, as Red Right Hand suggests (see link here: https://investorshub.advfn.com/boards/read_msg.aspx?message_id=176128955), Northwest’s application may not yet in the backlog, if they took 6 months (180 days) to respond to the first RFI, and took up to 90 days to respond to a second RFI, putting them at 420 days - 180 (1st RFI) - 90 (2nd RFI) = 150 days.

However, regarding RRH’s theory that we are not part of the backlog because the application may only be at Day 150, I think that’s doubtful, and here’s why:

First, the MHRA states the following:

The assessment of your response to the first RFI will be completed by Day 150 (60 calendar days after the procedure restart date) and we will notify you as follows:
If your response has addressed all our questions, we will notify you as soon as possible that your application is undergoing final compliance checks.

If we identify minor outstanding issues, we will send you a second RFI letter by Day 150 (see section 2.5).

If there are outstanding major objections which if unresolved would preclude a marketing authorisation or orphan designation, you will receive a CHM letter by Day 150 (see section 2.6).

We will stop the clock when we send out a second RFI or CHM letter.

https://www.gov.uk/guidance/national-assessment-procedure-for-medicines

MHRA states they’ll send out the first RFI by Day 90. So if MHRA were on schedule, Northwest would have been at about Day 90 when they presumably received their first one. From the same link:

By Day 90 (90 calendar days after the start of the procedure) we will send you the first request for information (RFI) and switch off the clock. The RFI will be a consolidated list of questions covering all sections of the dossier, including orphan designation if applicable. We may also send you relevant assessment reports and annotated product information documents. The RFI may include ‘major objections’ which, if unresolved, would preclude a marketing authorisation or orphan designation.

Using the March 7, 2024 Validation date, then the RFI might have arrived by approximately June 7, 2024. If they took 6 months to answer them (as is allowed), then that would have taken us to around December 7, 2024. And yet we know from the 2nd Q (August 9, 2024) that,

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

And then in the 3rd Q (November 12, 2024), the company states,

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.
https://www.sec.gov/ix?doc=/Archives/edgar/data/1072379/000141057824001879/nwbo-20240930x10q.htm

So if Northwest took 6 months to respond to the first RFI, it’s extremely doubtful that any inspections would be taking place, nor being scheduled during that clock-off time. Instead, it would seem that by August 9 (note that is about 60 days after the first 90 days when the RFI is supposed to be sent out by MHRA - and again using the March 7 as the validation date), the clock was back on and inspections were being scheduled. That means, then, that if say by August 1 (I’m just spitballing) the clock was back on, and all the inspections soon after began, which rumor has it on this board went on through late January, early February 2025, then the application would be at around 330 days… well over the 150 days that MHRA cites that they would send a second RFI letter, identifying any “minor outstanding issues”.

So my thinking is that we aren’t in a second or third RFI, and that all of the inspections are completed, and so I’m hoping that any pop quizzes the company might be receiving are all part of the final process before MHRA hands down their decision. I don’t think the DCVax-L application is part of that disadvantaged group of applicants with major objections, as I think the application has well passed that part of the process hurdle a long while ago.

Instead, IMO, the DCVax-L application is one of the MHRA's backlogged applications, and I think that we are not one of the ones with any major objections that are hurtling us back to a CHM meeting.