NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

That’s simply not true. There are many precedents for companies pursuing approvals outside the U.S. first — especially in the UK and EU:

• Holoclar® (stem cell therapy for corneal damage) — EMA approval in 2015, never filed in the U.S. (Novartis decision).

• Strimvelis® (gene therapy for ADA-SCID) — EMA approval in 2016, not filed in the U.S. (later sold to Orchard).

• ChondroCelect® (cartilage cell therapy) — EMA approval in 2009, never filed with FDA due to resources.

• Alofisel® (darvadstrocel for Crohn’s fistulas) — EMA approval in 2018; U.S. filing later withdrawn when FDA requested additional data.

• Kymriah® (CAR-T, Novartis) — FDA approved in 2017, but EMA/UK approval and NHS access followed quickly in 2018, with UK patients treated early.

For these:

• Yescarta® and Kymriah® (CAR-T therapies) — both launched through EU/UK approvals and NICE access agreements around the same time as FDA approval, with NHS patients treated even before full U.S. commercial rollout.

And for me, one other company I was invested in did Japan first, then the US, a few years later and yes, they were approve by the FDA. Another cellular therapy company I am invested in had a number of smaller markets in Asia, outside of the US, before focusing on the US, and is also approved by the FDA.

Clearly, the idea that “nobody does MHRA or Europe first” is false. For advanced therapies (ATMPs), Europe often leads.

Now, for NWBO specifically:
• They already have a UK manufacturing plant, certified by the MHRA.
• They secured Promising Innovative Medicine (PIM) designation and entry into the UK’s Early Access to Medicines Scheme (EAMS) — something the FDA does not even offer.

• Glioblastoma is a UK health priority, and NWBO partners with King’s College London, one of the top neuro-oncology centers worldwide.

Given this, it makes perfect sense to file in the UK first. They had infrastructure, regulatory designations tailored to cell therapies, political will around GBM, and premier academic collaborators. And approval in the UK carries weight with other regulators, who often credit MHRA/EMA reviews.

So let’s be clear: NWBO didn’t “go shopping” because the FDA rejected them. They pursued a rational strategy — leveraging UK strengths in ATMP regulation and glioblastoma research to secure the first approval of murcidencel.

As for your claim NWBO was told not to file in the US first, you have zero evidence to make that claim but your flatly wrong speculative nonsense. You made it up. We know it. You know it. You pulled it out of your rear.

Secondary clarification: why some drugs go EU/UK first

It’s also worth stressing that none of the therapies listed above were “rejected” by FDA. Companies either:
• deliberately filed in Europe first (Holoclar, Strimvelis, ChondroCelect, Alofisel), or
• filed both but Europe/UK moved just as quickly (Kymriah, Yescarta).



Clearly, the claim that “nobody does MHRA first” is false. For advanced therapies (ATMPs), Europe and the UK have often been the lead markets.

In short, FDA refusal has nothing to do with it. Filing in Europe or the UK first is a strategic and sometimes advantageous choice. For NWBO, UK-first reflects exactly that: a rational strategy consistent with how other advanced therapies have been advanced.