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.
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