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Re: Hbpainter post# 523820

Friday, 10/21/2022 2:41:58 PM

Friday, October 21, 2022 2:41:58 PM

Post# of 695572
Can someone who knows more than me clarify if our ECA design falls under this new FDA guidance? I would think that historical clinical data is more robust than RWD and sets a higher bar, though I see the two concepts are separated:

https://www.clinicaltrialsarena.com/analysis/real-world-data-charge/

The FDA guidance addresses RWD, but not really ECAs consisting of historical clinical data. Again, I would think NWBO’s ECA is made of higher quality data than RWD, but looking for others’ thoughts on this. Thanks.
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