Replies to post #774219 on NorthWest Biotherapeutics Inc (NWBO)

[manibiotech]

And for ATLs education , here is AI summary, as he has been repeatedly posting same excerpt from FDA guidance which is not relevant to DcVax trial

“ No, Northwest Biotherapeutics’ DCVax-L phase 3 trial would not be considered a non-interventional study under the FDA’s definitions in the August 2023 guidance you linked (Considerations for the Use of Real-World Data and Real-World Evidence).

Here’s why:
• The guidance defines interventional studies (clinical trials) as those in which participants are assigned to one or more interventions according to a study protocol to evaluate effects on health outcomes (e.g., randomized controlled trials, single-arm trials) ?.
• In contrast, non-interventional (observational) studies analyze data on patients who receive a marketed drug during routine medical practice and are not assigned to an intervention by a study protocol ?.
• The DCVax-L phase 3 trial was a randomized, placebo-controlled clinical trial where patients with glioblastoma were actively assigned to receive either DCVax-L or a placebo, following a predefined protocol—not observed passively in routine care.

Because assignment to treatment or placebo was determined by the study protocol, the trial is firmly classified as interventional, not observational (non-interventional).”

[GPha]

Mani, quoting a single paragraph without understanding the full context of the FDA’s 2023 RWE guidance is why no one takes your posts seriously anymore. You linked the document but clearly didn’t read it. Or worse, you read it and didn’t understand it.

Let me help you out since reading comprehension isn’t your strong suit:
The FDA clearly states that data from products used in clinical practice under EUA counts as valid RWD. This includes structured data from compassionate use programs. It’s not a gray area; it’s in the text. If NWBO captured patient-level outcomes during compassionate use, it can be used as RWE.

The paragraph you’re repeating discusses ensuring access to patient-level data, not banning non-trial data. It tells sponsors to engage early with the FDA and ensure transparency, which is common sense, not a prohibition.

So what is your argument? That NWBO needs an RCT to support its BLA because one paragraph mentions discussions with review divisions? That’s not biotech insight; that’s just pretending to be in biotech.

You’ve been pushing this misguided narrative for years. It's tiring. Either read the full document and understand what “real-world data” means or maybe consider choosing a name that better reflects your understanding.