Avecho completes meeting with TGA confirming pathway for Phase III Clinical Trial
Avecho is pleased to advise it recently completed a meeting with the Australian Therapeutic Goods Administration (TGA), where the Company presented its final Phase III clinical trial design and planned submission strategy.
The TGA has not recommended any changes to the trial design and submission strategy and the program will commence as planned.
Avecho CEO, Dr Paul Gavin, said:
“We have maintained transparent dialogue with the TGA as we approach the imminent commencement of our Phase III trial. We were very pleased with the reception we received for decisions made in the design of our program. This most recent meeting allows us to commence patient recruitment with confidence that a successful result may lead to a favorable assessment of this treatment by regulators and commercial partners. With the largest and most robust Phase III CBD trial in Australia to date, the Avecho team is eager to get started and is carefully planning each step forward to yield a positive outcome.”
Avecho expects to commence recruitment for the Phase III trial this month, with a total of five sites to be used for the study, located in Melbourne, Sydney, Central Coast, Brisbane and Perth.