They have approved that many drugs that they have no real idea outside of a hypothesis to how they work, methoxyflurane for example or propofol, I think if they know it works when given at the appropriate time (at the point where the patient is deemed steroid refractory and with msb stem cells which are 50% more potent then previous trials which failed), it’s safe and it’s an unmet need then they have to approve it and can request further investigation at a later date. Simple as that.
They have approved that many drugs that they have no real idea...
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