CBD soft-gel product design complete
Avecho Biotechnology Limited (ASX:AVE) has today announced the appointed manufacturer of our cannabidiol (CBD) soft-gel product, Catalent, has completed the composition and design of the dosage form intended for TGA registration.
The soft-gel product is the focus of our Australian clinical trial campaign to support registration, starting with our recently approved Phase I PK study.
This is an important milestone on the development pathway for our CBD product. It is vitally important to get the chemistry, manufacturing and controls aspect of the formulation correct – so we have been thorough in our approach to this, ensuring we produce a GMP finished product that is appropriate for scale up and registration with the TGA.
In parallel with this work, we are now finalising plans to meet with the TGA to discuss our entire development program, with a view to defining the clinical indication and supporting pivotal trial design.