Nemaura Medical (NASDAQ: NMRD) Reports Positive Data from Early Head-to-Head Comparison |
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Nemaura Medical (NASDAQ: NMRD), a clinical-stage drug platform company addressing Alzheimer’s disease, Parkinson’s disease and other neurodegenerative diseases, announced positive initial user-volunteer data from its head-to-head comparison with a major incumbent CGM device.
Why It Matters: Earlier this year Nemaura announced that following discussions with various healthcare insurers, it was planning head-to-head comparisons with one or more major incumbent CGM devices. The aim of these studies was to position sugarBEAT® as a cost-effective, flexible alternative to marketed invasive CGM, allowing continuous glucose monitoring on days the user chooses, and therefore, we believe, reducing the overall cost burden to users and healthcare insurers alike. Today, the Company reported early results comparing data between sugarBEAT® and a major incumbent CGM device, demonstrating sugarBEAT® accuracy comparable to the incumbent CGM device, using a single finger stick calibration. Further details can be viewed on a report published on the company’s website at: https://nemauramedical.com/publications/
Key Quote: “he primary objective of these user studies comparing sugarBEAT® with marketed CGMs was to demonstrate that similar long-term clinical outcomes can be achieved irrespective of whether CGM is used every day of the month or only on a few days of the week or month. We believe that the implications of this would be that the annual cost per user would dramatically fall, making it affordable for the 90% of the diabetic population that are Type 2, the majority of whom do not require continuous daily monitoring, and those persons with Type 1 diabetes who are not currently using any CGM for whom having an occasional daily glucose profile would provide a powerful insight into the control over their blood sugar levels and Time-in-Range profiles.” – Dr. Faz Chowdhury, CEO
The Backstory: Nemaura is a medical technology company developing micro-systems-based wearable diagnostic devices and currently commercializing sugarBEAT™, and proBEAT™, sugarBEAT®, a CE mark approved Class IIb medical device, is a non-invasive and flexible continuous glucose monitor (CGM) providing actionable insights derived from real time glucose measurements and daily glucose trend data, which may help people with diabetes and pre-diabetes to better manage, reverse and prevent the onset of diabetes. Nemaura is planning to submit a PMA application for sugarBEAT® during the second quarter of 2020 for FDA review of this device under medical device regulations. proBEAT™ comprises a non-invasive glucose monitor and a digital healthcare subscription service and is due to be launched in the US as a general wellness product.
Disclosure
Nemaura Medical (NMRD) is a client of RedChip Companies. NMRD agreed to pay RedChip a monthly cash fee of $5,000 for six months of investor awareness services. RedChip also received 20,000 shares of Rule 144 stock for services performed between December 2018 and May 2019.
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CytoDyn (OTCQB: CYDY) Clarifies Status of Biologics Application |
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CytoDyn (OTCQB: CYDY), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, clarified the status of the Company’s submission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for leronlimab as a combination therapy with HAART for highly treatment experienced HIV patients, filed on April 27, 2020 with the FDA.
Why it Matters:The BLA will not be considered completed until the Company submits to the FDA clinical datasets required to address FDA comments it received in March 2020, as described in the Company’s press releases on May 4 and May 6, 2020. CytoDyn expects to submit these clinical datasets on May 11, 2020. After the BLA submission is deemed completed, FDA makes a filing decision and sets a PDUFA goal date. CytoDyn has Fast Track designation for leronlimab and a rolling review for its BLA, as previously assigned by the FDA and the Company plans to request a priority review for the BLA. A priority review designation, if granted, means the FDA’s goal is to take action on the application within six months of receipt (compared with 10 months under standard review).
The Backstory:CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients. CytoDyn initially filed its BLA in April 2020 to seek FDA approval for leronlimab as a combination therapy for highly treatment experienced HIV patients. CytoDyn is also conducting a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients. CytoDyn plans to initiate a registration-directed study of leronlimab monotherapy indication. If successful, it could support a label extension.
Disclosure
CytoDyn (CYDY) is a client of RedChip Companies, Inc. CYDY agreed to pay RedChip Companies, Inc., a $20,000 quarterly cash fee, beginning in February 2020, for RedChip investor awareness services.
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Esports Entertainment Group (NASDAQ: GMBL) Signs Binding LOI to Acquire Online Sportsbook and Casino Operator Argyll Entertainment |
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Esports Entertainment Group (NASDAQ: GMBL), a licensed online gambling company with a focus on esports wagering and 18+ gaming, signed a binding Letter of Intent (LOI) to acquire LHE Enterprises Ltd, the holding company of online sportsbook and casino operator Argyll Entertainment AG and its operating support subsidiaries (”Argyll”).
Why It Matters: Since launching its flagship brand,www.sportnation.bet, in the summer of 2017, Argyll has established itself as a fast growing and innovative gaming company within the UK and Irish market leveraging the expertise of its 40 strong staff in marketing, technology, risk management, and regulation to offer its customers an entertaining, safe and secure online gaming experience, an award winning rewards program, and access to exclusive and proprietary sports and gaming content.
Key Quote: “With Argyll already generating around $12 million in revenue annually, this acquisition will have a major positive impact for our company. In the current global environment of COVID-19 there has been a surge of interest in online gaming to fill the void left by traditional sports and other activities. Argyll’s established footprint and revenue base, combined with our strong cash position from our successful April capital raise combined with our esports betting platform, places Esports Entertainment in a great position to capitalize on this evolving opportunity.” - Grant Johnson, CEO
The Backstory: Esports Entertainment Group is a licensed online gambling company with a specific focus on esports wagering and 18+ gaming. Esports Entertainment offers fantasy, pools, fixed odds and exchange style wagering on esports events in a licensed, regulated and secure platform to the global esports audience at vie.gg. In addition, Esports Entertainment intends to offer users from around the world the ability to participate in multi-player mobile and PC video game tournaments for cash prizes. Esports Entertainment is led by a team of industry professionals and technical experts from the online gambling and the video game industries, and esports. The Company holds a license to conduct online gambling and 18+ gaming on a global basis in Curacao, Kingdom of the Netherlands.
Disclosure
Esports Entertainment Group, Inc. (GMBL) is a client of RedChip Companies, Inc. GMBL agreed to pay RedChip Companies, Inc. a $4,000 monthly cash fee, beginning in June 2018, and 225,000 shares of Rule 144 stock for RedChip investor awareness services.
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Quote of the Week |
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"In this business, if you're good, you're right six times out of ten. You're never going to be right nine times out of ten"
- Peter Lynch, Chairman of the Lynch Foundation |
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