Replies to post #766942 on NorthWest Biotherapeutics Inc (NWBO)

[SkyLimit2022]

Thanks for posting the link to the full document!

We will be able to gauge just how big this news is by the flurry of panicked posts that are likely to come from the fuddy buddy committee!

Luckily, readers & investors are empowered to do their own fact-checking and their own research! ✅️

In my view, IFR eligibility may soon become irrelevant with the pending MAA decision—but it’s still awesome to see that IFR access is now available while we await MHRA’s forthcoming decision!



NHS England

NHS Commissioning Policy IFR

AI Fact-Checking

[beartrap12]

Thanks again, GGB, for printing the meanings of all those different UK funds where money can come from for alternate gov't funding sources. I had not gotten to it.

[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