NorthWest Biotherapeutics Inc (NWBO)

[dennisdave]

Utter BS once again What the MHRA really said (verbatim):

“Many of the general principles would be relevant for external controls drawn from other sources, such as previously completed clinical trials.”

The MHRA explicitly includes ECAs made from prior clinical trials as being within the scope of the draft.
It says the same methodological standards (pre-specification, bias mitigation, etc.) should apply — not because it’s "real-world data," but because it’s still external and subject to bias. It does not claim clinical trial ECAs are literally equivalent to RWD — but that’s not the point. The point is that both are valid inputs, and the draft is meant to handle both under the same regulatory principles.

The MHRA only applies this guidance to RWD."=> False — it explicitly says the guidance is also relevant for ECAs built from previously completed clinical trials.
"RCT-based ECAs aren't covered under this."=> False — the whole point of the consultation is to give the MHRA policy flexibility for different types of external control arms, including pooled RCTs like those used in DCVax-L.

You are trying to draw a false dichotomy: "If it’s not from electronic health records or insurance data, it can’t be included."
But the MHRA itself is saying: "No — if you're using external controls, whether from real-world settings or old trials, here’s how we’ll evaluate them."
That includes DCVax-L. Period.

Btw you claim the MHRA said something that you made up thats why you refuse to add a link to the MHRA page and quote the MHRA. Ex does that also all the time. Its called lying.