This is a usual part of the FDA process and much like a discussion between MSB and the FDA.
We have MANY drugs and therapeutic products that HAVE BEEN APPROVED throughout the world with different regulatory bodies, despite not exactly understanding or knowing the mechanism of action. Case in point - PARACETAMOL (PANADOL) which to this day is one of the most widely used painkillers. There is no consensus on its mechanism of action
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Ann: FDA Advisory Committee Sets Review Date for Remestemcel-L, page-534
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