TGA pre-submission meeting for insomnia related CBD soft-gel product
Avecho Biotechnology Limited (ASX:AVE) today announced it is proceeding to a pre-submission meeting with the Therapeutic Goods Administration (TGA) to present plans for the development and registration of its pharmaceutical grade cannabidiol (CBD) soft-gel product for an insomnia related indication.
This follows the TGA’s decision in December to allow the sale of registered pure CBD products as a Schedule 3 (S3) pharmacist only medicine in Australia. The meeting will examine the appropriateness of Avecho’s planned clinical program to support S3 product registration, and will also address specific design aspects of the pivotal phase III study, together with the available safety information related to the cannabidiol and the specific soft-gel product.
Avecho CEO, Dr Paul Gavin said: “We are committed to working closely and constructively with the TGA and other key regulators as we develop our clinical trial program and products, to ensure our Company is primed to register our CBD soft-gel product in key markets. We have engaged the Cannvalate team to run the TGA pre-submission meeting, due to their extensive experience in the Australian medicinal cannabis space with an emphasis on TGA interactions.”
Avecho’s complete product development strategy will be refined after the TGA pre-submission meeting and presented to market in Q3.