Replies to post #787924 on NorthWest Biotherapeutics Inc (NWBO)

[QL300]

The fact that NWBO did do it in the UK first discredits your first point of "nobody does MHRA first. There is no record of the FDA telling NWBO anything. It's pure conjecture. Show me proof. 
By the way, not everyone does the FDA first.  Look at Alecensa, Opdivo, Lonsurf and Eloxatin.  All approved elsewhere prior to the US. Another bullshit claim debunked. 

[Roman516]

No Grow, just the facts!

Per your comments,

"NOBODY does MHRA first. It is not a market that oncology marketers make much if any profit. U.S. is the gold mine and everybody who does trials under FDA jurisdiction, does it intending to file in the U.S. first. All other country regulators give FDA approved drugs faster reviews and most approve it based on the FDA's decision. But FDA told NWBO they didn't have sufficient clinical evidence to file. So NWBO had to find another country to file. UK is not a market anybody does first AFTER doing FDA sanctioned trials. That's the facts and the way it is playing out"

Once again per your comment, "But FDA told NWBO they didn't have sufficient clinical evidence to file". Ok, than provide the proof in writing that the FDA said this to NWBO.
DCVax works and has little to no side effects yet many drugs in the USA are approved and have major side effects and many can cause death but are allowed to be approved????
The real questions are based on $$$$ over the welfare of the patient based the fact that the BPs need to dump their products on the US market in order to sustain their S-CURVE profits. Otherwise, their stock prices would tank and perhaps drive them out of business, IMPO.
The sad part of this is that DCVax works and should be approved, but we already know that DCVax-L and DCVax-D would disrupt the markets for the BPs and that is a fact, IMPO. The real sad part is that many people are and will die based on lack of approval, greed, BPs and MMs corruption and that is a fact as well, IMPO.

[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.

[meirluc]

"NOBODY does MHRA first. It is not a market that oncology marketers make much if any profit"

Not true. You were already informed last night via post 788126 that a number
of companies first pursued approvals outside the USA (FDA). Nevertheless you
have decided to repeat your misinformation.

Yes, FDA approval is a gold mine unless one's BLA nixes the products of the
BP companies that are among the heavy FDA contributors. Although not the
only reason, that may have been one of the reasons that NWBO opted to submit
its application first to the MHRA.