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07/04/25 2:13 PM

#774189 RE: manibiotech #774170

manibiotech,

That is exactly what I said. True approval ONLY comes with approval of the BLA. This allows for subjective interpretation by those in any advisory committee or at the time of the final vote for approval or recommendation. Approval of the SAP only comes as part of the approval of the overall application at which time precedent might be set. MHRA approves the SAP ahead of time. Best wishes.