Thread by @FlemmingBruce

Murcidencel's Global Recognition & NHS High Cost Drug List

MILESTONE

1/18

Murcidencel, the WHO-assigned INN for DCVax-L, has achieved major regulatory milestones:

Included in WHO INN Proposed List 128 (2023)

Advanced to WHO INN Recommended List 90 (2023)

Confirming global recognition for NWBO's DC vaccine.

NHS: April 1st.
NICE: April 2nd.

2/15

The WHO INN Recommended List 90 explicitly describes Murcidencel as:

Autologous DCs derived from glioblastoma patients

Pulsed with tumor lysate

Grown with GM-CSF & IL-4

This matches DCVax-L’s manufacturing process perfectly.

3/18

This is an exact match to DCVax-L's manufacturing process as detailed by NWBO and published clinical data.

WHO’s description mirrors DCVax-L's method:

DCs from patient blood
Tumor lysate for immune recognition
Maturation with GM-CSF and IL-4

4/18

✅ FINAL Version Labeling:

🇬🇧 On April 1, 2025, Murcidencel was officially listed in the NHS High Cost Drugs List (Version 20.0 – Final).

It’s marked for cancer treatment, aligning with its use in high-risk pediatric and GBM applications.

5/18

✅ FINAL Version Labeling:

NHS lists are updated biannually (April & October).

When labeled "FINAL," it means full approval for the 2025–2026 period—no draft, no provisional.

6/18

📌 Changelog Confirms Inclusion:

The April 1, 2025 update lists Murcidencel for Specialist Centre use.

It’s also approved for Shared Care with Secondary Care, expanding patient access.

7/18

🏷️ Access Through IFR:

Murcidencel is available through Individual Funding Request (IFR).

IFR allows clinicians to apply for case-by-case access even before full NICE appraisal.

8/18

🌐 Real-World Data Pathway:

IFR-based access enables real-world clinical data collection.

This data is crucial for supporting NICE evaluation and broader commissioning

9/18

Why IL-12 is Not an Issue:

The Czech trial uses IL-12 in maturation but remains Murcidencel under WHO standards.

WHO INN lists focus on the core platform—dendritic cells + tumor lysate—not maturation specifics

10/18

🚀 Regulatory Alignment:

Murcidencel’s WHO INN status allows for global regulatory harmonization.

It simplifies EMA, FDA, and MHRA applications under a universally recognized name.

11/18

🏥 Strategic Advantage for NWBO:

Being listed in the NHS High Cost Drugs List signals early adoption by a major healthcare system.

NHS listing is a precursor to NICE Technology Appraisal and full commissioning.

12/18

🔄 Conditional Access → Full Commissioning:

IFR success stories strengthen the case for full NHS funding.

This opens the door for broader UK patient access and real-world outcome tracking.

13/18

💡 Market Credibility Boost:

The NHS listing, combined with WHO INN certification, enhances Murcidencel’s market reputation.

It positions NWBO for strategic partnerships and potential EMA PRIME or MHRA EAMS designations.

14/18

🧠 Why This Matters for Investors:

NHS listing validates Murcidencel's therapeutic value, making it more attractive for partnerships.

IFR-based real-world data can de-risk regulatory pathways.

15/18

🔎 Next Catalysts to Watch:

Monitor IFR outcomes for real-world data.

NICE appraisal progress is the next major milestone.

Expansion into EMA and FDA filings now becomes more streamlined.

16/18

📌 NHS and NICE Coordination:

Murcidencel’s inclusion in the NHS High Cost Drugs List on April 1, 2025 & NICE’s confirmation of ongoing MHRA MAA engagement on April 2, 2025 signals strategic alignment.

NHS is likely preparing for broader access once the MAA is approved

17/18

🚀 Pathway to Full Commissioning:

IFR-based access enables real-world data while the MAA process completes.

Positive IFR outcomes strengthen Murcidencel’s case for NICE appraisal.

This dual-track approach accelerates UK market entry.

18/18

💡 Investor Confidence Boost:

NHS listing + MHRA MAA + NICE Liaison = Strategic UK rollout.

This alignment is a clear regulatory path for Murcidencel’s NHS entry.

Investors should watch for NICE Technology Appraisal as the next milestone.