NorthWest Biotherapeutics Inc (NWBO)

[The Danish Dude]

Are we approved? Well, very probably.

✅ Key Takeaways from MHRA Data (March 2025)
According to the new MHRA Performance data (thanks Stonkmaster for heads-up), this is stated:

📌 Medicines Licensing Applications:

“On 31 March 2025, we cleared all backlogs related to licence applications for innovative and established medicines.”
“All new national licence applications submitted after 1 September 2024 continue to be assessed within our target of 210 days — with an average timescale of 160 days in March.”

📍 NWBO’s MAA Timeline
MAA validation date: March 7, 2024

150-day clock completion (standard review): August 4, 2024

Possible clock-stops (RFI or major objections): Add 60–90 days

Total time with clock-stop: November 2024 to January 2025

Now: Mid-April 2025

This means we are well past the regulatory decision window under both standard and extended review scenarios, and now fully within the period typically reserved for:

Administrative finalisation

Labeling/packaging confirmations

Price negotiations (if applicable)

Manufacturing release verification

Public RNS timing strategy by sponsor

🚦 Is the Product Approved?
Technically:

We cannot say it is formally “approved” unless MHRA or NWBO publicly confirms it.

However:
Given MHRA's 100% clearance rate, zero backlog status, and average approval time of 160 days (which NWBO has now exceeded by >40 days), it is reasonable to infer that:

🟩 The scientific assessment of DCVax-L is complete and positive.
🟨 The file is now in final administrative or announcement phases.

🧠 Why This Strongly Suggests NWBO is in Post-Approval Phase
MHRA Performance Data confirms no active backlog and adherence to 210-day clock (avg. 160).

NWBO submitted before Sept 2024, which means their file falls under the now-cleared queue.

If DCVax-L had been rejected, NWBO would have been required to disclose it in an 8-K.

NWBO’s silence + clean performance data = high likelihood of pending publication.

Flaskworks was likely part of the data reviewed, as established in the Feb 6, 2024 PR using “substantial comparability” language.

🔒 Conclusion
While formal approval is not publicly confirmed, it is highly likely that:

✅ The scientific review has been completed
✅ No clinical efficacy trial was required (per biosimilar/comparability guidelines)
✅ NWBO is now in a post-review administrative phase
✅ Final steps (e.g., RFI responses, packaging, timing of announcement) are underway

🚨 This is functionally the same as being “approved” pending public disclosure.

Great news, and what could be better than to enjoy that during the day where Judas betrayed Jesus. Great analogy.

Now prepare for the ressurection.

We will all surely miss Nemesis18



Speaking of which .... HyGro!

Well HyGro, we have all enjoyed the output from your brillant unenlightened mind, that has sparked thousand of hours of due diligence, to continously refute your bias incentivized nonsense.

Guess you don't understand the requirements of demonstrating equivalency of different manufacturing processes.

So, once more.

🧪 What Does NWBO Need to Prove About Flaskworks EDEN?
NWBO must demonstrate that DCVax-L produced with Flaskworks EDEN is comparable to the manually produced DCVax-L used in their Phase 3 trial — in terms of quality, safety, and efficacy.

This is not the same as proving biosimilarity the way a generic or follow-on biologic would. Instead, it is a “manufacturing change” within the same product platform.

🔬 Understanding the Difference: Comparability vs. Bioequivalence
When evaluating manufacturing changes or follow-on products in the biopharmaceutical world, two distinct regulatory concepts are used: comparability and bioequivalence.

✅ Comparability — Applies to NWBO and Flaskworks EDEN
What it means:
Comparability is used when a company changes how it manufactures an already approved product, but the product itself remains the same.

Purpose:
To demonstrate that the new manufacturing process — such as switching from manual production to the automated Flaskworks EDEN system — does not impact the product’s safety, purity, potency, or efficacy.

Regulatory requirement:
If robust analytical, functional, and potency data show the product is substantially comparable, then no new clinical trial is required.

NWBO's case:
Since DCVax-L remains the same product, NWBO must prove comparability, not bioequivalence.

⚖️ Bioequivalence — does NOT apply to NWBO and Flaskworks EDEN
What it means:
Bioequivalence is used when comparing two different products — typically a biosimilar or generic version of a reference drug — to prove they behave the same in the body.

Purpose:
To show that the new product has similar pharmacokinetics (PK) and pharmacodynamics (PD) to the original.

Regulatory requirement:
Clinical studies are often needed unless well-validated PD biomarkers are used. This pathway is not relevant for NWBO’s internal manufacturing change.

🧠 Bottom Line:
NWBO is NOT developing a different product.

They are simply transitioning DCVax-L from manual production to an automated process (Flaskworks EDEN).

Therefore, they follow the comparability pathway, not the bioequivalence route.

This is why, under MHRA and FDA guidance, clinical trials are not required — only well-designed comparability studies.

✅ Why NWBO Does Not Need a Clinical Trial for Flaskworks DCVax-L
🇬🇧 MHRA (UK) – Guidance on Licensing of Biosimilar Products (2022)



According to the MHRA’s 2025 guidance on biosimilars, clinical efficacy trials are no longer a default requirement — and may be waived entirely when robust comparability is shown:

“In most cases a comparative efficacy trial may not be necessary if sound scientific rationale supports this approach.”
— MHRA, Guidance on Licensing of Biosimilar Products, Section 6.3.2

The key requirement is a scientific justification that the new product behaves comparably to the original. This includes matching:

Binding properties

Functional characteristics

Biological activity

As the MHRA further clarifies:

“A justification should be provided that comparable efficacy can be derived from comparable binding properties and functional characteristics.”

In other words, if NWBO’s Flaskworks-manufactured DCVax-L shows analytical and functional comparability with the manually produced version — using assays and validated potency markers — no new clinical efficacy trial is required.

This is precisely what NWBO signaled in their February 6, 2024 press release, stating that Flaskworks-produced DCVax-L had shown:

“Substantial comparability” to the manually produced product.

That language is highly significant — it aligns directly with regulatory terminology used when clinical efficacy trials are no longer required, because comparability has already been established through scientific data.

✅ FDA: Why NWBO Does Not Need a Clinical Trial
🔬 Flaskworks DCVax-L vs. Manual DCVax-L — Functional & Analytical Comparability Is Enough



The FDA has clearly and repeatedly stated that clinical efficacy trials are not required when biosimilar products can demonstrate:

Analytical similarity

Functional comparability (e.g. potency, cell surface markers, mechanism of action)

Pharmacodynamic or pharmacokinetic (PD/PK) data where appropriate

🔹 1. FDA’s 2023 Summary: Efficacy Trials Can Be Waived
In 2023, the FDA launched a dedicated page to reinforce that clinical trials may be omitted if PD markers and analytics are sufficient:

“Without a comparative clinical efficacy study, the FDA has clarified that biosimilars may be approved based on pharmacokinetic (PK) data and PD biomarker data.”
— Center for Biosimilars, April 2023

🔹 2. FDA: PD Biomarkers Can Be More Sensitive Than Clinical Outcomes
The FDA explains that PD markers are often more sensitive than clinical endpoints for detecting differences:

“PD biomarkers that reflect the mechanism of action of the biological product have the potential to be more sensitive endpoints for detecting clinically meaningful differences between two products.”
— FDA Guidance, 2023

These biomarkers — like those likely used to test Flaskworks' DCVax-L — are sufficient to demonstrate biosimilarity, especially when they are mechanism-based, such as showing dendritic cell maturation and T-cell activation.

🔹 3. FDA on Totality of Evidence
The FDA emphasizes a “totality of evidence” approach. If NWBO demonstrated that Flaskworks-made DCVax-L matches manual production in:

Phenotypic markers (CD80, CD86, HLA-DR, CD83)

Cytokine profiles

Functional potency (e.g. T-cell activation in vitro)

Release criteria

…then the FDA would not require a separate efficacy trial, because no clinically meaningful difference can be expected.

“Comparative clinical studies may not be necessary if the biosimilar demonstrates strong analytical similarity and similar biological activity.”
— FDA’s Biosimilarity Guidance (Scientific Considerations, 2015; reaffirmed 2023)

✅ Conclusion: Language & Context Matter
When NWBO chose the phrase “substantial comparability” in their PR, they did so in the context of regulatory readiness — just weeks before the MHRA validated their MAA.

Combined with:

MHRA’s published policy that trials can be waived if comparability is shown

The PR’s timing (Feb 6), and

The explicit mention of Flaskworks-produced product data,

…it strongly supports that NWBO submitted comparability data sufficient to avoid a clinical trial — and that “substantial comparability” was used to reflect exactly that.