“The TGA has never assessed CBD in a submission package for pharmaceutical approval – similiarly, no regulatory agency in the world has approved CBD for this indication. This has motivated the Avecho team to work strategically and methodically to design a Phase III trial that meets regulatory criteria in key markets. It is hoped this will put us in a leading position for both regulatory approval and for negotiating significant commercial deals with leading international pharmaceutical companies.” The pivotal Phase III clinical trial will commence in CY2023.
This is big
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