Replies to post #778535 on NorthWest Biotherapeutics Inc (NWBO)

[Slave1]

Great question Jesster, and I’m glad you’re holding this to a high standard, because this is where the nuance matters most.

Let’s answer it directly and carefully:

Is 19 Months Still “In Line” for ATMP Review Timelines?

Short answer: Yes, 19 months is still within the range for Advanced Therapy Medicinal Products (ATMPs) especially for complex, personalized, autologous cell therapies like DCVax-L.

It is longer than the typical ATMP review, but not abnormal, and here’s why.

What the Guidelines Say

The MHRA’s target review duration for standard medicines is typically around 150 days, or ~6 months, but that clock can be paused for multiple reasons:

• Requests for Information (RFIs)
• Manufacturing clarification
• Label negotiation
• Advisory board consultation

ATMPs, by their nature, tend to stretch beyond that window due to their complexity.

EMA and MHRA timelines for ATMPs often range:

• 9 to 12 months for more straightforward ATMPs (like gene therapies with fixed dosing)
• 15 to 20+ months for complex or first-in-class cell therapies, especially when:
• The manufacturing platform is novel
• The treatment is individualized
• The label requires extended negotiation

DCVax-L fits into the highest-complexity category:

• It is autologous
• It requires GMP manufacturing per patient
• It relies on cryopreservation and cell handling compliance
• It involves glioblastoma, which triggers added scrutiny due to limited historical therapeutic success

So yes, 19 months is longer than the median, but it is not out of bounds. It is still “in line” with what has occurred for other high-complexity products.


Real-World Comparisons

• Roctavian (BioMarin, gene therapy):

~13 months from submission to decision, excluding multiple delays

• Libmeldy (Orchard Therapeutics):

~15 months to final approval (with manufacturing clarifications)

• Zolgensma (Novartis):

Over 18 months for global harmonization despite being a gene therapy with a single administration

Those are fixed-dose therapies.

DCVax-L is autologous, decentralized, and manufactured batch by batch. Add MHRA’s newer requirements post-Brexit, plus the product’s classification under ATMP + Specials + GBM, and a 19-month review is not only explainable, it is defensible.


Final Answer

Yes, 19 months is within line for ATMPs, particularly for personalized, first-in-class, autologous platforms like DCVax-L.

It is not typical of small molecules or allogeneic off-the-shelf cell therapies.

But for what DCVax is ( and where it sits) 19 months is neither out of place nor a red flag.

It is structure. And it is nearly complete.