Replies to post #774388 on NorthWest Biotherapeutics Inc (NWBO)

[Slave1]

You’re completely missing the point, so let’s break it down simply:

In 2022, the MHRA approved a Pediatric Investigation Plan (PIP) for DCVax-L that used the same matched external control methodology as the adult Phase 3 trial. That means the MHRA formally accepted the design as valid for regulatory use. It’s right there in the public PIP summary:

“The PIP is based on the same study design as the adult Phase III trial, with a contemporaneous matched external control group instead of a randomized control.”

    MHRA PIP Summary, July 2022 (P/223/2022)

That approval alone undercuts your entire argument.
Let’s walk through your claims:

1. “It’s not pivotal.”

Irrelevant. The significance isn’t in the phase, it’s in the MHRA’s acceptance of the evidence model. They didn’t just allow exploration. They allowed regulatory development using the exact same ECA-based framework. That’s not common, and it’s not accidental.

2. “Prespecified means before enrollment.”

Yes, and that’s exactly what happened. The use of external controls was pre-declared in the adult trial’s protocol and approved by regulators. The MHRA’s own guidance talks about prespecification because it’s a bar for trustworthiness, not a gotcha. DCVax-L cleared it.

3. “It’s not the same SAP.”

That’s just false. The pediatric plan explicitly adopted the adult trial design, including its control methodology and endpoints. Adjustments in secondary endpoints do not change the fact that the survival analysis structure, the backbone of both trials, is shared.

And as for your claim that the PIP “won’t be used”? That’s pure speculation. The submission of the PIP was a legal requirement under EU and UK law to advance the MAA. It wasn’t “hype.” It was regulatory groundwork, and it was approved.

You can dislike Linda Powers all you want, but this isn’t about her. The MHRA made a clear, documented decision. They accepted the same trial design you’re claiming is disqualifying. That’s not marketing spin. That’s regulatory precedent.

[biosectinvestor]

Guidance is GUIDANCE. You try to beat people up with narrow readings absent contrary evidence and context, and the guidance is not hard and fast and they themselves say so. They make exceptions all the time, where it makes sense and in rare diseases. But the reality is, they did prespecify, it just was not in a manner that would be done NOW typically, but as I just explained, in another post, your posts insisting on rules that are not rules, and requirements that are not hard and fast requirements, just blows smoke up everyone's rear ends. You harp on notions that have been fully addressed, just not practically possible at the time they started the trial but appropriately addressed in a manner likely worked out directly with regulators... You are not a regulator, and of course you can insist on rigidity, but that's not the reality of regulation in such contexts. The FDA is not going to make them start a P3 all over again, when there are reasonable ways to address the issue. I know it fits within the notion that some like to promote, that regulators are inflexibly stupid and impractically minded, but that's not typically true. But in order for shorts and Adam Feuerstein to "look like they know something", such viewpoints have to be CONSTANTLY reasserted and rehashed. I see Ada resurfaced as have you.