458 0 Kommentare MedMira Reports First Quarter Results FY2021 - Seite 2

Regulatory Status
MedMira has applied to the US FDA to obtain FDA Emergency Use Authorization (EUA) for the REVEALCOVID-19 Total Antibody Test, and its application is under review. However, while awaiting the authorization, REVEALCOVID-19 Total Antibody Test can be distributed in the U.S. according to Section IV.D of the Policy for Coronavirus Disease-2019 Test. In addition, MedMira received on the 21^st of May 2020 the right to sell in all countries accepting CE mark. In Canada, the Company has re-submitted, based on the new template issued by Health Canada, its application for an interim order permitting sales on the 29^th of October 2020. No sales can be made in Canada prior to receipt of the interim order from Health Canada. There can be no assurance when or if the interim order will be granted.

The Company’s financial statements and management’s discussion and analysis are available on the Company’s profile on SEDAR at www.sedar.com. For matters of going concern, reference is made to the Auditor’s Emphasis of Matter statement in the fiscal year ended 2020 Auditors Report and note 2b in the audited financial statements which are also available on SEDAR.

About MedMira

MedMira is the developer and owner of Rapid Vertical Flow (RVF) Technology. The Company’s rapid test applications built on RVF Technology provide hospitals, labs, clinics and individuals with instant diagnosis for diseases such as HIV and hepatitis C in just three easy steps. The Company’s tests are sold under the Reveal, Multiplo and Miriad brands in global markets. MedMira’s corporate offices and manufacturing facilities are located in Halifax, Nova Scotia, Canada and the Company has a sales and customer service office located in the United States. For more information visit medmira.com. Follow us on Twitter and LinkedIn.

This news release contains forward-looking statements, which involve risk and uncertainties and reflect the Company’s current expectation regarding future events, including statements regarding possible regulatory approval and sales of new products, future growth, and new business opportunities. Actual events could materially differ from those projected herein and depend on a number of factors including, but not limited to, changing market conditions, successful and timely completion of clinical studies, uncertainties related to the regulatory approval process, establishment of corporate alliances, the ability of distributors and other partners to fulfil obligations and deliver sales and other risks detailed from time to time in the company’s annual and quarterly filings available at www.sedar.com.

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

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