Monday, January 21, 2019 6:32:04 PM
22 January 2019 ASX Code: MXC
Major Regulatory Milestones Achieved for Pharma Business
? TGA has approved TGO93 Declaration Form, advising that our CTN (Clinical Trial Notification) for CogniCannTM into Alzheimer’s and dementia at the University of Notre Dame has been processed and is available in the Clinical Trials Repository
? Government approval for API Extraction at MXC’s European Facility - now one of the first EU facilities to be granted a full API extraction permit, issued by the Slovenian Ministry of Health. MXC can now develop its own THC, CBD and other Phytocannabinoids as API’s for the formulation of CannEpilTM, CogniCannTM and
future phytomedicines
? SME certification issued by the European Medicines Agency (EMA); providing access for scientific advice, drug evaluation and registration of CannEpilTM, CogniCannTM and additional Phytomedicines that the Company is developing. It also provides MXC the opportunity to obtain fee reductions up to 100% in the development and registration of priority medicines (PRIME)
? Each achievement delivers on the Board’s strategy and commitment to the growth of MXC’s pharma business and demonstrates the Company’s progress to deliver near-term commercial outcomes on its seed-to-pharma strategy
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