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Saturday, June 28, 2025 11:29:02 AM
The MHRA guidance states that design of external control arms from contemporary trials should follow the same principles as real-world data, not that clinical trial-generated ECAs are equivalent to RWD.
So your AI is confusing terms here, thinking that you're referring to ECAs generated only from real world datasets. Data from randomized clinical trials are not real world data.
All of these semantics just to point out that the MHRA is not drafting this guidance with DCVax-L specifically in mind.
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