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hoffmann6383

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hoffmann6383

Re: exwannabe post# 544614

Tuesday, 12/06/2022 12:35:20 PM

Tuesday, December 06, 2022 12:35:20 PM

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No RA has said that the changed trial protocol is valid for the purpose of approval.



Misleading. MHRA explicitly approved the trial protocol by green lighting a pediatric trial using the same SAP and the FDA implicitly approved the design by Finalizing their guidance on ECAs.

Have a great one buddy! by.
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