- AusCann (AC8) receives its official Memorandum of Conference (MoC) from the US Food and Drug Administration Centre for Veterinary Centre (US FDA-CVM)
- The MoC follows a successful meeting which was held in December last year to discuss the development program for AusCann’s cannabinoid-based veterinary medicine
- CPAT-01 is aimed at managing pain, inflammation and quality of life in dogs suffering from osteoarthritis
- AusCann is now progressing phase 2C and phase three trials to support a New Animal Drug Application as the next step towards US FDA-CVM approval for CPAT-01
- Company shares are up 18.6 per cent to trade at 8.3 cents
AusCann (AC8) has received its official Memorandum of Conference (MoC) from the US Food and Drug Administration Centre for Veterinary Centre (US FDA-CVM) for CPAT-01.
The MoC marked the next step in the FDA approval process following a successful pre-submission conference (PSC) meeting which was held in early December last year.
The PSC meeting was held by AusCann and the FDA-CVM to discuss the development program for the approval of CPAT-01 as a veterinary medicine for dogs with osteoarthritis.
The MoC essentially provides a formal guidance on the development program and regulatory pathway for the approval of the cannabinoid-based veterinary drug to assist with managing pain, inflammation and quality of life in dogs.
The meeting package summarised the CPAT-01 program, with specific questions related to submitting a New Animal Drug Application to get the CPAT-01 drug approved in the US.
In addition, AusCann received favourable recommendations relating to its approach to a
titration regimen for CPAT-01 to address the variability of cannabinoids. It also got confirmation that its development plan for safety and toxicology will be sufficient, therefore greatly reducing the time and cost required for the program.
AusCann has begun the design phase for its phase 2C clinical effectiveness trial to generate final pilot data. The data will be used to inform the design of a phase three program to support the New Animal Drug Application for the approval of CPAT-01.
Company shares were up 18.6 per cent to trade at 8.3 cents at 2:11 pm AEDT.