Laugh

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@PK_Fund It has a great look! Was well thought out!

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For the market experts out there...here's a company with a 1/4 of the market cap, but trades on a Nasdaq exchange ($REKR). If $NWBO would get back on to an exchange, would our institutional list look more like this?

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$NWBO institutional holders report. Saving this to compare to next quarter.

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@joeretired41 I was thinking similarly. It would be nice to see a few more trades of that dollar amount ($364.478.40) or higher go through before close.

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Funny thing...I thought I'd try the Google version of AI and ask the question. Here's a screenshot of the response. Notice $NWBO was the Google AI link. Other people have asked. Here's the associated link:

https://t.co/Pcj6fzMHqj

[cpamtm @cpamtm]

$NWBO

Per Co-Pilot AI when asked “What is the longest MHRA MAA review and approval ever?”

Here’s the clearest, evidence‑based answer you can get from public regulatory history — and it’s actually pretty fascinating.

There is no single officially published “record holder,” because MHRA does not maintain a public leaderboard of longest assessments. But we can answer this by looking at:

• Statutory timelines
• Historical outliers
• Known cases where reviews stretched far beyond the norm
• First‑in‑class or highly complex products that required multiple CHM cycles

And when you put those together, a pattern emerges.

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MHRA statutory timelines vs. real-world extremes

Standard statutory limit:

• 210 days for a national UK marketing authorisation (excluding clock stops) RAPS
• 150 days for priority or high‑quality dossiers (target, not guaranteed) RAPS

But these clocks stop during RFIs, company responses, CHM re‑reviews, and major scientific issues. That’s where extreme cases arise.

---

Documented long-duration MHRA reviews (multi‑year)

While MHRA doesn’t publish a “longest ever,” several categories of products have historically taken 2–4+ years from initial submission to approval due to scientific complexity, manufacturing issues, or repeated CHM cycles.

1. Advanced Therapy Medicinal Products (ATMPs)

Cell therapies, gene therapies, and autologous products often undergo:

• Multiple rounds of RFIs
• Manufacturing comparability reviews
• CHM re‑referrals
• Benefit–risk reassessments

Several ATMPs in the 2010s–2020s took 3–4 years from initial submission to final approval (publicly traceable through EMA-era UK participation and MHRA post‑Brexit national procedures).

2. Oncology products with novel mechanisms

Historically, some oncology submissions required 2–3 CHM meetings, stretching total review time to 2–3 years.

3. Products requiring major manufacturing remediation

When MHRA identifies CMC or GMP deficiencies, the review can extend well beyond 2 years.

---

So what’s the longest?

Based on all publicly traceable cases:

The longest MHRA review durations on record fall in the ~3–4 year range.

These involve:

• ATMPs
• First‑in‑class immunotherapies
• Products requiring multiple CHM cycles
• Applications paused for major CMC remediation

There are no publicly documented MHRA approvals exceeding ~4 years from initial submission to final authorisation.

---

Where does DCVax‑L fit in this context?

You’ve been tracking this closely, so here’s the strategic interpretation:

• DCVax‑L is a first‑in‑class autologous dendritic cell therapy
• It is exactly the type of product that historically falls into the longest MHRA review category
• A 2‑year review is not unusual for ATMPs
• Several ATMPs have taken longer (3–4 years) before approval
• There is no signal of refusal or appeal (which would be public)

So DCVax‑L is not approaching any historical “limit.”
It is still well within the range of long but normal ATMP review timelines.

---

Bottom line

The longest MHRA drug reviews ever documented are ~3–4 years, almost always involving complex ATMPs or first‑in‑class oncology products requiring multiple CHM cycles.

A 2‑year review is not unprecedented, not a negative signal, and not outside MHRA norms for this class of therapy.

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In the history of the MHRA, what is the longest it has taken for a decision to be made on an MAA? Has anyone done the research on this? It looks like $NWBO's application for #DCVax-L was filed on 12/20/2023, 881 days ago. Is this the longest?

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Does anyone in the #DCVax community know if $NWBO is involved in this clinical trial?
https://t.co/bVmuSlNPWd

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$NWBO's continued progress on multiple fronts...

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Haven't had a chance to read, but I see the 10-Q is out for $NWBO.

https://t.co/VIoW5ffSVf

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Information on $NWBO's MM settlement:

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The wording seems different here as it states "certain" upcoming capital and operating expenses?

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@joeretired41 @SouthernDrive21 @hoffmann6383 Will we know what the settlement amount is on an upcoming quarterly report?

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Tomorrow (5/12), $NWBO will close with ____________ volume and a ____________ price from today's (5/11) 7,322,199 volume and $0.25675 closing price.

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Sometimes I wonder if $NWBO is being held back because a shareholder like Bernie from the movie, "The Cooler" is keeping the company suppressed. If so, I hope I'm not Bernie!

https://t.co/KYnb6ncJVv

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@Investisco What do you mean that the big whales are in trouble?

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You'll have to adjust the chart history to "all" to see the history from their IPO in 2001.

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$EXAS is a company followed for many years. It seemed the FDA approval was the inflection point. Traded at one time below $1. Below is a wiki link to their history. Interesting read. Some similarities to the $NWBO journey.

https://t.co/2yEzcN2w8H
https://t.co/4eCNZnNRcZ

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@kellyfmcnamara $nwbo -url:discord

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Results of poll at open.

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One other $NWBO sentiment question. True or false. Volume today will equal or exceed 10 million shares.

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Back in April we had 4 straight trading days of 10+ million shares (4/17/25 thru 4/23/25)