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FDA Approves Tetra Bio Pharma Inc.’s (OTCMKTS:TBPMF) Drug Device CAUMZ For Fast Track Designation

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Tetra Bio Pharma Inc. (OTCMKTS:TBPMF) has announced that the US Food and Drug Administration has issued it with a favorable response regarding CAUMZ. This comes following the company’s previous announcement of a Type B meeting with the agency for CAUMZ.

Tetra sought Expedited Review for CAUMZ

CAUMZ is a drug-device combination product for the management of patients who have advanced incurable malignant cancer. This includes patients nonresponsive to treatment and having symptoms that standard of care cannot control. The company expects to offer information on the decisions taken by the FDA and also explain the implications of the decisions once the management assesses them.

The Type B meeting aimed at confirming the admissibility of CAUMZ for Expedited Review programs, including Fast Track and also Accelerated Approval. Equally, the meeting sought interpretation on the requirements for CAUMZ for New Drug Application as well as validation of the nonclinical safety program through indication. Similarly, the company sought guidance from the agency regarding study protocols to employ to bring the device to the market.

FDA gave Tetra nod to submit Fast Track application

The FDA usually provides the Fast Track designation for accelerated review of drug products treating life-threatening or serious conditions and those that fill unmet medical needs. The FDA gave Tetra a nod regarding the target population, saying that the condition was serious with considerable morbidity.

The company’s clinical data helped the management to conclude that CAUMZ will help in enhancing the survival of cancer patients and also impact on their day-to-day functioning. Regarding the unmet medical need, the patient population is refractory to available therapies, and thus, CAUMZ will offer an improved effect on the outcome of the condition.

According to the FDA, the company met the basic requirements for Expedited Review Programs and Fast Track. Therefore the company can proceed to submit the Fast Track designation application for review. Equally, the FDA reviewed the company’s Accelerated Approval for CAUMZ for its target population. The agency gave the company guidance on how to use the Patient-Reported Outcome tool to show the claimed benefit to the patients.

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Zenabis Global Inc (OTCMKTS:ZBISF) Posts Cannabis Revenues Of CAD $12.6 Million In Q1 2020

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Zenabis Global Inc (OTCMKTS:ZBISF) reported an increase of 18% in revenues in Q1 2020. It is on the backdrop of surging cannabis sales. The company expects to report continued growth going forward because of an improved footprint in the global markets and enhanced penetration into provincial markets. Zenabis has achieved cost savings of $10 million in each quarter and helps to grow business. It expects to realize the benefits of cost reductions in Q2 2020.

Developments in Q1

Zenabis produced vape cartridges for use with Era vapor devices of Pax Labs Inc initially. The company has sold vape cartridges from the initial run to three regional distributors.

Health Canada grants an export license to Zenabis

Health Canada has issued an export license to help Zenabis export cannabis in Q1 to the EU. The company shipped the first consignment to a partner in Malta in April 2020. It also fulfilled the PO received from an Israel based certified importer for bulk dried cannabis in May 2020.

As part of cost-cutting measures, Zenabis downsized its workforce by 22% at its head office and cannabis operations. The company’s Atholville facility has received nod of EU-GMP and expects to begin exports to the EU in Q3 2020. It also received approval from Health Canada for additional processing and growing regions at Zenabis Langley.

CEO of Zenabis, Kevin Coft, said the company is proud to receive EU-GMP approval together with Natrix Sciences Ltd, a partner based in the EU, and ZenPharm Ltd. The EU-GMP nod allows the company to ship medicinal cannabis in large quantities to the EU. ZenPharm can satisfy the demand of European customers, with high-quality medical-use cannabis. Zenabis holds a stake of 43.5% in ZenPharm, which is a JV formed with Natrix.

Annual packaging capacity – 7000 kg

The annual packaging capacity of ZenPharm is 7,000 kg. The company has to improve the packaging capacity to satisfy the demand in the EU as per shareholders’ undertaking. ZenPharm is negotiating with several potential clients in the EU to begin shipments.

Vice President (Strategic Development) of Zenabis, Olen Vanderleeden, said the association with ZenPharm provides an opportunity to sell medical cannabis in the EU and boost revenues.

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ENDEXX (OTCMKTS:EDXC) Reports An Increase Of 91% in Q2 2020 Revenues: Takes Over Retail Pro Associates

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ENDEXX (OTCMKTS:EDXC) reported revenues of $1.3 million (an increase of 91%) in Q2 2020. It is on the backdrop of improved sales of cannabidiol products, mainly Premium Blue topical and improved sales activity in e-commerce and wholesale channels. Premium CBD products are available at 6,000 retail stores across the nation.

Flexible e-commerce platform

Endexx, which has business as CBD Unlimited, introduced an e-commerce platform that allows customers to control their subscription models. The customers can either delay or extend the subscription when reordering. CBD Unlimited customers are flexible in experimenting with products and dosages. The customers can know more about the best product dosage suitable for them and choose the wellness products for ordering. They can also order online and choose a pick up from their nearest location.

Expands store count in Q2

CBD Unlimited increased the number of stores in Q2 to provide super-premium and premium products. Its R&D team is undertaking initial testing of forthcoming Trail-R-Mix equine products, which will be introduced towards the end of this year. The company expects to expand the store count over the long term to more than 100,000. As part of its strategy to promote growth across the world, the company signed accords with distribution partners in the Caribbean, North America, and the Polynesian markets.

Purchases Retail Pro Associates

CBD Unlimited has taken over Retail Pro Associates Inc (RPA) in May 2020. The acquisition allows the company to focus on the distribution and sales of good quality supplements for the animals. It expects to strengthen and grow its Pet and Equine product lines by adding a management team with expertise in the Pet and CPG industry.

CBD Unlimited selected RPA considering the knowledge of the management team in health and total wellness products. Vice President (Marketing and Sales) of RPA, Stephen Herron, will play a vital role in promoting Equine and Pet divisions of CBD Unlimited.

Herron will share his experience in drug, food, and mass retail channels to guide the team at RPA. CEO and Chairman of CBD Unlimited, Todd Davis, will lead the management to promote growth.

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Marijuana Company Of America Inc (OTCMKTS:MCOA) Updates On JV Project In Oregon: Reports Revenues Of $695,096 From Its hempSMART Products

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With the state of Oregon allowing essential services during COVID-19 pandemic, Marijuana Company Of America Inc (OTCMKTS:MCOA) managed to operate its hemp farm without any disruptions taking the help of CBA (Covered Bridge Acres). CBA adopted all safety measures to ensure hassle-free operation of the farm.

Satisfies flower and biomass demand

CBA is engaged in growing high cannabidiol hemp since acquiring the Scio farm in the year 2018 and satisfies the demand for flower and biomass. However, the sales of these products are sluggish because of the coronavirus crisis and excessive production in 2019. To promote growth, CBA will focus on growing high-quality cannabigerol (CBG) flower at its greenhouses. CBG flower satisfies the demand for a smokable flower segment.

Production of smokable buds

CBA will utilize SCROG cultivation method to grow hemp and allow the average production of up to 90% tops from each plant. The company will produce smokable buds by trimming the tops. It will apply high-quality nutrients at the right time to improve the development of aromatic and dense buds used in the final product. The company aims to maintain leadership in the Smokable cannabigerol flowers and meet the growing demand. Though CBA booked initial sales of biomass in 2019, coronavirus has impacted the marketing of other products. The company is exploring opportunities to book sales in other areas.

Reports a year-on-year growth of 175.7%

Marijuana Company has reported revenues of $695,076 in 2019. It represents a year-on-year growth of 175.7%. The company’s assets dropped to $1.143 million (down 40.4%) in 2019.

Substantial savings on hempSMART products

hempSMART is offering its products at a discounted rate allowing customers to enjoy significant savings. The country is reopening its economy on a cautious note, and people who emerge from their homes, can strengthen their immunity and keep away illnesses. When the customers shop at its site, hempSMART donates a small portion of the sales to support nurses, doctors, first responders, and hospital workers every week.

HempSMART Global is developing its innovative digital platform that supports hemp products for a wider base of consumers. On an ongoing basis, the company supports philanthropic partnerships.

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