AC8 0.00% 4.0¢ auscann group holdings ltd

Ann: AusCann Successful in Tender with Tasmanian Dept of Health, page-19

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    A flurry of positive news expected in the coming weeks!!
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    1. Registration of Dermacann in South Africa
    Registration of DermaCann® as a herbal supplement with the South African Department of Agriculture, Forestry and Fisheries. On 11 October 2020 Cannpal announced, "CannPal is working with a local partner to provide regulatory support in relation to the Company’s application for the registration of DermaCann® with the Department of Agriculture, Forestry and Fisheries (DAFF) to be registered as a herbal supplement for commercialisation within the country. The registration of DermaCann® in South Africa will complement the Company’s Australian and New Zealand regulatory dossiers, presently being drafted for submission. There are an estimated 2.5 million medicalized dogs in South Africa and an estimated 20% suffering from atopic dermatitis or skin disease, providing an ideal pilot regulatory market for launching DermaCann® through the veterinary channel ahead of Australia and New Zealand registrations".

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    2. DermaCann® U.S Commercialisation


    Announcement by by Cannpal on 11 October 2020 :The Company is also pleased to announce that it has entered into a manufacturing agreement with a U.S based Company, Vetio Animal Health, to commence manufacturing activities for the commercialisation of DermaCann® in the United States in early 2021.Vetio is a leading Contract Development and Manufacturing Organisation in America dedicated to animal health with a focus on cGMP compliance (current Good Manufacturing Practices) to the highest industry standards. Certain states in America have introduced favourable legislation for pet products containing or consisting of hemp-derived cannabidiol, which allows CannPal an opportunity to leverage its robust product dossier to capitalise on both the evolving hemp-derived CBD market headwinds, as well as the traditional canine skin health market in the U.S.The global canine skin and dermatitis market is worth over US$1b globally, and the launch of DermaCann® will provide the veterinary market with a unique CBD-derived and clinically validated product to be used as a beneficial therapy in a canine atopic dermatitis management regimen.

    3. The commencement of Neuvis study for neuropathic pain


    Auscann announcement on 30 April 2021:

    The 60-patient Investigator-led study of the THC:CBD hard-shell capsules using the Neuvis® platform for the treatment of neuropathic pain has been temporarily delayed to allow for amendments to be made to the protocol. These revisions are designed to align the study protocol with the positive observations seen by clinicians using Neuvis® for specific age groups and sub-populations. Ethics approval for the improved study design is expected to be granted in mid-2021.

    4. Micromax commercial manufacturing


    Auscann announcement on 30 April 2021 : CannPal is now in the process of transferring from pilot scale production to a commercial manufacturing
    partner to enable the Company to manufacture novel microencapsulated ingredients using its MicroMAX® technology, for the development of animal health products at scale.


    5. Commencement of Dermacann TAS study


    Auscann announcement on 30 April 2021: During the quarter CannPal commenced the acclimatisation phase for a 15 dog, 90 day Target Animal Safety (TAS) study in the United States to complement the Company’s manufacturing, toxicological and clinical efficacy data pack. The live phase of the TAS study is expected to be completed in H2 2021 and will be used to help support widespread adoption for DermaCann® in the veterinary community.
    6. New drug submission of CPAT 01

    Cannpal announcement 29 October 2020 : Communications with the Office of New Animal Drug Evaluation (ONADE) within the Food and Drug
    Administration, Centre for Veterinary Medicine (FDA-CVM) are ongoing and The Company expects to hold its pre-submission conference (PSC) with the regulatory agency once all study reports have been finalised.




    Best wishes to all the current and prospective holders!!







 
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