In a major achievement for its product development pipeline, the MGC Pharmaceuticals Limited has received formal approval by the TGA for its TGO93 Declaration Form, informing that its CTN (Clinical Trial Notification) has been processed and is available in the Clinical Trials Repository. The approval allows MGC to initiate its Phase IIB Clinical Trial on Dementia and Alzheimer patients with UNDA in WA, and start the recruitment of patients, using its second GMP certified IMP (investigative medicinal product) CogniCannTM. The trial has been approved by the Human Research Ethics Committee and will focus on the effects of the medicinal cannabis treatment on the symptoms of mild dementia and Alzheimer's and the improvement of patient's quality of life, at the University of Notre Dame, Western Australia. Receipt of TGA approval signals the start of patient recruitment and the 16-week trial remains on track to commence in first half of 2019. During the trial, CogniCannTM specifically formulated by MXC, will be tested on a total of 50 patients aged 65 and over, alongside a series of pre and post-treatment surveys and focus groups that will be used to assess the effects of the product.