Other jurisdictions have approved the use of Penthrox without the need for further trials as there is sufficient regulatory documents to support marketing approval. The FDA however have requested a Phase 3 trial at a cost of $15million to support marketing approval in the US. Perhaps Dr Gottlieb would be a change agent for deregulation, maybe he would also want to support the approval of a device that addresses in part narcotics abuse in the US. It could go the other way of course since upheaval in the department could extend the time to approval. Who knows?
Other jurisdictions have approved the use of Penthrox without...
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