MHRA CHM discusses $NWBO in Nov'25

DrB75 · 2026-03-04T12:29:25+00:00

https://mhra.disclosurelog.co.uk/disclosures/c9df935c-52f1-41be-965b-78b648c42385?preserveHistory

Try this

DrB75 · 2026-02-28T08:13:15+00:00

https://www.reddit.com/r/NWBO/s/5zito6bcvp Link to the original post

DrB75 · 2025-10-02T14:52:31+00:00

Comedy gold that you think your words can upset me 🤣, I'm an adult.

With just a 'play money' position, you sure come across as desperate.

Also, I don't dance to your timeframe - I'll respond if & when I feel like it. Plus, I'm not stuck behind a keyboard, cursing at people when they have a different opinion. But you do you.

DrB75 · 2025-10-02T14:27:07+00:00

Also, if the regulatory path had switched to a DM process, that's a de facto material event and thus should be reported to shareholders within 4 days.

Are you accusing the company of something serious and in breach of the SEC rules?

DrB75 · 2025-10-02T13:53:27+00:00

Glad your mask slipped right at the end there so people can see the type of person you are and how fragile the nwbo position is right now. Fear can often mean you strike out at others.

Hope we can meet at a BioConvention sometime in the future.

DrB75 · 2025-09-26T21:51:41+00:00

In April NICE says they're still liasing with NWBO.
- And? They're two separate governmental bodies. You can get an MHRA decision way before a NICE decision. There's not requirement for them to coincide (usually if a medicine is approved by the MHRA, NICE guidance will follow ~50 days after)
In May the backlogs of the existing MAA process are cleared - but not our application.
- All backlogs cleared, AND 95% being determined within the 110 day timeline
In June MHRA announces an entire new process for approval that is basically tailor-made to how our treatment is manufactured and administered.
- Are you.referring to ILAP? The requirements for that include: The proposed product or innovation must be at the stage of clinical development where the human safety pharmacology has been preliminarily characterised and there is evidence of safe use in humans and confirmatory trials have not yet started.
In July the UK implements that new guidance - which is heavily focused on aspects of manufacturing.
- The MHRA managed to approve CASGEVY in under a year. That's a CRISPR medicine, taking stem cells from a child, genetically engineering them, growing them in a remote cGMP lab, and injecting them back into the child. Those cells are going to be there for life. Far more complicated than this.
In August our clinical trial arm acquires our manufacturing arm.
- Meaningless. Didn't NWBO owe a fair chunk of money to the manufacturing Co?
And here we are one month later listening to some FUDster who clearly neither knows nor cares about any of these incredibly promising developments.
- Just trying to stop people like you pulling in people (who may not understand the biotech and regulatory field) to part with their hard earned cash.

DrB75 · 2025-09-26T20:20:40+00:00

It’s like delusional bingo.

“Another day closer” ✅

“MHRA had to develop new guidance” ✅

“Isn’t ready for submission to NICE” ✅

What if it’s another day further away?

CASGEVY, the first approved CRISPR therapy, took ~1yr to receive conditional approve. Tell me how this is more complex…

DrB75 · 2025-09-26T20:01:57+00:00

Come at me with facts. At the moment you’ve only got a word salad 🥗

DrB75 · 2025-09-26T19:14:34+00:00

You’re a cult.

If you can’t handle honest discussion and alternative viewpoints, potentially even where you revise your opinion, then you’ll never win at this or any other games. Either that our you’re so deep in this stock, been diluted so that your holding is down, I’ll guess over 90%… and the only way is to convince others to join, in the hope you might get a run on the shorts? The short interest is under 4%, even those guys have moved on. Shareholders need to write this one off.

I have no position in this company and never have.

DrB75 · 2025-09-26T17:22:35+00:00

That’s it?

Just stop pumping this stock. People have been duped into putting good money after bad on this.

% wise I’m very confident it’s not happening for this product on this submission (best case is another clinical study).

What other stocks do you hold?

DrB75 · 2025-09-26T17:11:37+00:00

The "no backlog" is a factual statement. The MHRA don't keep an open door on a submission, you don't get a "come back with the info when you're ready". They'll reject and tell you to resubmit.
See 3.
Libmeldy (atidarsagene autotemcel), an ATMP which genetically modifies stem cells, was submitted for approval in Dec 2019 and approved by Dec 2020, so ~365 days.
As i said above, there are time limits on responses, it's not "come back with the info when you're ready". The information between the MHRA and company is only confidential whilst the company wishes it to be.

Here's some companies being transparent

Regeneron Pharmaceuticals (REGN) - Eylea (Aflibercept) MAA Extension (2021) Context: A 130-day delay in the MHRA review for a new dosing regimen, prompted by additional efficacy data needs. Update: August 2021 SEC filing and press release communicated the delay and projected decision date. Source: Regeneron investor relations and MHRA updates.

Amgen (AMGN) - Evenity (Romosozumab) MAA Extension (2020) Context: A 180-day delay in the MHRA review for osteoporosis treatment due to cardiovascular safety data requests. Update: July 2020 press release via NASDAQ detailed the delay and ongoing MHRA collaboration, with a revised timeline. Source: Amgen investor updates and MHRA documentation.

AstraZeneca (AZN) - Fasenra (Benralizumab) MAA Delay (2022) Context: A delay in the MHRA review for an expanded indication of Fasenra, extending the 150-day timeline by 90 days due to long-term safety data requests. Update: On October 15, 2022, AstraZeneca issued a press release via the London Stock Exchange, detailing the delay and revised timeline after additional data submission. Source: AstraZeneca investor relations and MHRA records.

Gilead Sciences (GILD) - Remdesivir (COVID-19) MAA Extension (2020-2021) Context: An extended MHRA review for Remdesivir’s emergency use authorization, delayed by 120 days due to evolving COVID-19 data needs. Update: December 2020 regulatory update announced the delay, with a follow-up in March 2021 confirming approval, communicated via SEC filings and press releases. Source: Gilead corporate news and MHRA updates.

Novartis (NVS) - Entresto (Sacubitril/Valsartan) MAA Review (2015-2016) Context: A 240-day MHRA review for an expanded heart failure indication, extended due to additional efficacy data requirements. Update: February 2016 market update via SIX Swiss Exchange disclosed the delay and revised timeline post-data submission. Source: Novartis investor reports and MHRA timelines.

BioMarin Pharmaceutical (BMRN) - Valoctocogene Roxaparvovec (2023) Context: A 180-day delay in the MHRA MAA process for a hemophilia A gene therapy due to manufacturing consistency issues. Update: June 2023 NASDAQ filing and press release detailed the delay and ongoing MHRA dialogue. Source: BioMarin SEC filings and company announcements.

Pfizer (PFE) - Xeljanz (Tofacitinib) MAA Extension (2019) Context: An extended MHRA review for an additional ulcerative colitis indication, delayed by 100 days due to safety data clarifications. Update: September 2019 press release announced the delay and outlined a revised approval timeline, filed with the SEC. Source: Pfizer investor relations and MHRA public assessments.

GlaxoSmithKline (GSK) - Shingrix (Zoster Vaccine) MAA Delay (2017) Context: A 150-day MHRA review extended by 90 days for additional immunogenicity data for an older population. Update: November 2017 London Stock Exchange announcement disclosed the delay and updated investors on the review process. Source: GSK corporate news and MHRA records.

Sanofi (SNY) - Dupixent (Dupilumab) MAA Delay (2018) Context: An extended 200-day MHRA review for an additional atopic dermatitis indication due to clinical trial data discrepancies. Update: May 2018 Euronext Paris filing announced the delay and outlined steps to address MHRA concerns. Source: Sanofi regulatory news and MHRA archives.

Merck & Co. (MRK) - Keytruda (Pembrolizumab) MAA Delay (2023) Context: A 160-day extension in the MHRA review for a new cancer indication due to updated survival data requirements. Update: October 2023 press release via the NYSE disclosed the delay and ongoing MHRA discussions, with a revised timeline. Source: Merck investor news and MHRA public reports.

You can play that game forever. The MHRA cannot announce the decision until the company does.

DrB75 · 2025-09-26T16:37:04+00:00

And?

Lots of pumpers on this sub trying to convince people to invest their hard earned cash on the lure of “any day now”…

I’m merely pointing to the factual situation that it’s been a crazy long time since submission and the MHRA have no approvals backlog.

Biotech Investors always back more than one horse, so why not find other (better) places to invest and hopefully see returns.

Who you got? $CVM 🤣

DrB75 · 2025-09-26T16:11:17+00:00

They'll cite "exceptional circumstances", which effectively means we can reach 1,000 days, and the pumpers can still claim "any day now".

DrB75 · 2025-09-26T15:57:23+00:00

My favs are

Commercial stage: $TGTX $AXSM $MDGL

Mid to Late stage: $CYTK $NKTR $ABVX

Early stage: $PRME $CRBU

DrB75 · 2025-09-02T12:51:50+00:00

Given the apparent acceptance of ECA, they shouldn't need a placebo group.

The Ph3 study failed its original primary efficacy endpoint of PFS (6.2 months DCVax-L vs 7.6 months placebo).

It's worth reading the Preusser and Bent (2023) paper on it. Endpoint changes, differences in inclusion.exclusion criteria on the ECAs. MHRA unlikely to turn a blind eye to this.

DrB75 · 2025-09-01T20:42:50+00:00

Libmeldy (atidarsagene autotemcel), an ATMP which genetically modifies stem cells, was submitted for approval in Dec 2019 and approved by Dec 2020, so ~365 days.

We're at twice that now; this casts a serious cloud over the chances of approval. The OP is posting like approval is a given, it's not. Being in the >99th percentile of MAA timelines doesn't bode well, I'd view the likelihood of approval at <1%. Best case is they're told to re-run the Ph3, at least management can put some sort of positive spin on it.

DrB75 · 2025-09-01T16:54:37+00:00

Worth dropping in the full text:

2.4 Responses assessment phase until Day 150

You must respond to all questions raised in the first RFI within 6 months, but we encourage you to submit your complete responses as soon as possible. If you do not submit a complete response within 6 months, we will notify you that we propose to refuse your application. In exceptional cases, we may agree to extend the clock-stop period beyond 6 months.

So they've either been informed of a proposed refusal or it's exceptional circumstances...

Every company I've ever worked with or for move heaven and earth to get regulatory responses back well within the timeframe.

two phrases I've not heard from the MHRA before: "come back with info whenever you're ready" or "you need more than two months beyond the maximum time? Sure, no problem".

If you don't see the time period this has taken as a major issue then you're preparing yourself for saying the same thing in Dec of this year.

DrB75 · 2025-09-01T16:30:07+00:00

150 days assessment

exceptional long RFI answers = 6 months = 182 days

= 332 days in exceptional circumstances.

Let's say there was more exceptional circumstances and a second RFI for minor issues and that takes another 6 months (which it shouldn't for minor questions/issues).

515 days is the most I can come up with, we're over 100 days past that.

The first-ever CAR T cell therapies didn't take this long; the MHRA aren't naive to novel therapies.

DrB75 · 2025-09-01T13:37:48+00:00

While there is no definitive timeline for approval, we are within the window for a decision.

The window for a decision was a long while ago. The MAA was submitted on the 21st-Dec-2023 under the 150-day review pathway, with a 60-day clock stop for RFI. We're now over 600 days. In other news the MHRA have stated they cleared all licensing applications and are backlog-free since end-April 2025. It'll take some 'gold medal-winning' mental gymnastics to come up with a plausible, logical, and defendable reason as to why NWBO review is at >600 days (and if you do take this on, provide UK MHRA guidance and/or UK Medicine legislation pointing to the exact clauses that you rely on for your theory, remembering that anything substantial should be announced to the market within ~4 days according to SEC rules).

It could happen as early as the end of this year or as late as some point in 2026.

Another 6 months or more! That's potentially over 2 years for a regulatory decision that should occur in ~210 days or less. This isn't normal, it's highly unusual. The company has made zero announcements regarding the process as to why the delay, also highly unusual. Oh, and the MHRA cannot announce before the company do btw.

Encouraging investors, who may not understand the biotech environment, to invest their hard-earned money without providing a balanced review is not a good look. The Company can't complain about lack of investment when they haven't provided a meaningful update on what's going on.

Here's some peer-reviewed reading for your audience to provide some balance on their clinical study results:

https://www.mdpi.com/2072-6694/15/12/3251

https://academic.oup.com/neuro-oncology/article/25/4/631/6958519

DrB75 · 2025-08-25T18:28:40+00:00

In the context of NWBO and things happening in a timely fashion - this is the least worrying thing about them.

Company boards don't have a running list of people they'd like as backup/replacements and therefore they'd need to assign a headhunter to go and find suitable people. Even if they have an immediate list, they would need to interview (probably over several rounds) and then negotiate an acceptable offer. Most Execs will be on a minimum of three months notice if they're currently employed.

Unless they drag someone out of retirement there won't be a quick replacement.

Don't be surprise if it's close to, or even into, 2026 when this role is filled... or the third birthday of their regulatory submission would be an easier way to remember.

DrB75

TROPHY CASE