Approval with an additional trial required is still approval. Most drugs have some degree of a P4 trial. The range of requirements for that P4 vary widely. They vary from a full on, large N trial, to enhanced monitoring of patient complaints and everything in between.
I think your nuance is without a difference. Blarcamesine will be approved or it won't. The financial impact will be approximately the same whether a P4 is required or not.
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