NorthWest Biotherapeutics Inc (NWBO)

[muee88]

Do you think it would be included on that list if the MaA was going to be denied?

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In short: very unlikely.

Inclusion on the NHS High Cost Drugs list before MAA approval strongly suggests that denial is not expected — or at the very least, that NHS England is preparing for a probable approval, not a rejection.

Here’s why:

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1. NHS England doesn’t list investigational therapies arbitrarily

The High Cost Drugs List is not a list of drugs “under review” — it’s a commissioning and access management tool used only when there’s a realistic expectation of clinical use.
• If a therapy were likely to be rejected by the MHRA, there would be no need to plan for IFR pathways, assign its cost/commissioning status, or label it as an ATMP for specialist centers.
• Inclusion signals that internal stakeholders (NHS, MHRA, and possibly NICE) have some alignment or positive expectations about approval — even if formal decisions are still pending.

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2. NHS England protects its credibility and avoids premature listings

NHS England is conservative about listing unapproved treatments — particularly expensive and high-profile ATMPs like Murcidencel (DCVax-L). Listing it prematurely would:
• Create false hope among clinicians and patients
• Spark political and media pressure if it were later rejected
• Undermine NHS England’s own gatekeeping and commissioning framework

So they would not include it lightly unless there was a strong expectation of approval or access need.

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3. Inclusion helps facilitate immediate access upon approval

Because DCVax-L is a complex ATMP, infrastructure, clinical protocols, and funding pathways need lead time. By listing it early, NHS England is:
• Enabling specialist centres to prepare
• Setting up IFR pathways so patients can access it immediately post-approval in exceptional cases
• Avoiding delays in high-demand situations (like aggressive cancers)

That groundwork would be wasted if they expected a rejection.

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4. This isn’t standard for all pending MAAs

Very few therapies make it onto this list before they’re approved. The fact that Murcidencel is already listed — even in a limited, non-routinely commissioned form — means it’s been internally evaluated for operational feasibility and clinical potential.

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TL;DR:

No, Murcidencel almost certainly wouldn’t be on this list if NHS England believed the MAA was heading for rejection.
Its inclusion is a strong signal that:
• Approval is likely or considered plausible
• NHS England is actively preparing for controlled access
• It’s being taken seriously at the policy level, not just as an experimental therapy