no i remain of my opinion that ATL is promoting a failure of the application for the reasons I provided and for the nonsense he is posing.
NWBO is not using RWD whatever the hell you think that is
NWBO didn’t use Real World Data in the traditional sense (e.g., EHRs, registries, or wearables). And I never claimed they did. But they did use patient-level data collected outside of their own clinical trial, which the MHRA now explicitly says falls under the same regulatory principles as RWD-based ECAs Thats what Im saying. Again the key is this quote from the 2025 draft guideline:
“Many of the general principles would be relevant for external controls drawn from other sources, such as previously completed clinical trials.”
This includes NWBO’s data — pooled from contemporaneous, peer-reviewed RCT control arms. It’s not RWD by strict definition, but the MHRA treats it as functionally equivalent for purposes of bias control, protocol alignment, and regulatory acceptance.
Try to read my post more carefully before making claims as you did
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