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Galzus Research

06/04/25 10:09 AM

#770285 RE: dennisdave #770280

Dennis, you only need to read the MHRA guidance on what "real-world data" is. IE, it is data coming from any source THAT IS NOT A CLINICAL TRIAL.

Prior clinical trial datasets are not real-world, which the MHRA guidance does clarify as being from databases and similar sources.

This differs from the "real-world evidence" that the DCVax-L study used. Indeed, clinical trials are real data, and they were collected in the world. But the guidance from the MHRA is very clear here. The use of a constructed external control arm does not meet the definition of "real-world data."

You appear to be reading more into that than I intended. People are taking the release of this guidance as evidence that the MHRA is going to be approving DCVax soon, and by your own assessment, it is political cover. The guidance, however, is completely removed from the DCVax phase 3 trial. Therefore, coincidental.

It is evidence for nothing related to NWBO. Not in favor of approval. Not in favor of rejection.
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learningcurve2020

06/04/25 10:37 AM

#770295 RE: dennisdave #770280

No,Galzus is correct. The RWE probably refers things like Specials.