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Re: ahp123 post# 315895

Friday, 10/09/2020 12:53:17 PM

Friday, October 09, 2020 12:53:17 PM

Post# of 822893
I don’t FDA ever “accepts” an SAP outside of the SPA process. They just give feedback which is non-binding. My guess is that NWBO submitted the EMEA accepted language and got positive feedback from FDA or they would be cautious to make the change.
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