BOD ‘way ahead of nearest competitor’ Bod Science CEO, Jo Patterson, told Stockhead that in order to get ARTG registration, a company would have to undergo a ‘gold standard’ clinical trial, which is usually a double blinded placebo trial. “The product obviously has to meet the specifications that the TGA has outlined for a low dose CBD product, and it also has to be for a specific indication,” said Patterson. BOD’s insomnia trial has been two years in the planning, and at least 12 months in the making, recruiting 198 patients in total. “And now we’re about to lock the database and analyse the top line results which will be ready around mid to late August.” Patterson acknowledged there are other cannabis companies looking at the opportunity of bringing a Schedule 3 product to the market, but said they are still a long way behind BOD. “Some are still waiting for ethics approval, while others have got ethics approval, but haven’t started recruiting. I’m not aware of any that have actually started a trial. “So we are a long way ahead of the nearest competitor, and it gives us a good first mover advantage,” she said. Globally, Patterson said that US-based Jazz Pharmaceuticals (GW Pharma) is the only company to have had a CBD product approved and registered with a regulator. (Jazz’s cannabis-derived epilepsy drug Epidiolex won its FDA approval back in 2018.)
Source: Stockhead