Re: PVCT123: Could shut down of Aussie P3 be due to effort to focus on TGA AA route?
The Australia PV-10 phase III trial ended due to no viable comparator drugs; i.e., Australian physicians would not treat melanoma patients with outdated chemotherapy drugs, and Amgen does not make TVEC available in Australia due to the decision by PBS to not pay for the drug. Consequently, the termination of the Australia phase III trials had nothing to do with the new TGA provisional accelerated approval process. I am pleased to see the TGA has finally adopted an accelerated approval process. I have worked with US, German and French medical device manufacturing companies that sought TGA approval for their medical devices in Australia, and the TGA bureaucracy made the FDA look fast. Historically, a new drug or medical device that received accelerated approval in the United States, still had to go through the full trial process to obtain TGA approval in Australia. The Australia TGA provisional accelerated approval process is very new, and will likely experience typical bureaucratic startup delays. Any drug company applying for TGA provisional accelerated approval will likely encounter frustrating delays that will offset to some degree the benefits of the new program. Regardless, the new process provides potential promise for a quicker pathway to TGA approval for drugs that satisfy the new program's eligibility requirements.