NRx is pleased to announce that last week a revised Investigational New Drug module on the manufacturing of ZYESAMI™ (aviptadil) was submitted to the US Food and Drug Administration (FDA), containing documentation that confirmed Nephron Pharmaceuticals, Inc. is prepared to supply ZYESAMI on a commercial scale. This module will now be used as part of the FDA’s rolling review process in support of the New Drug Application for ZYESAMI.
Today, NRx also received notification that a European Qualified Person Auditor (European QP) has completed an inspection at a separate manufacturing facility with no adverse findings and awaits a QP Declaration that is required by the EU regulatory authorities for the release of ZYESAMI. The audit was completed in preparation for submission of European Union (EU)-standard ZYESAMI to EU and United Kingdom health regulatory authorities. Under EU law, a QP Auditor is responsible for certifying that each batch of a medicinal product meets all required provisions when released from a manufacturing facility within the EU or imported into the EU.
Finally, NRx notes that Relief Therapeutics Holdings issued a press release advising of a complaint filed in the Supreme Court of the State of New York against NeuroRx. The company vigorously disputes the allegations made in the press release and intends to defend its position in court. These events do not in any manner affect our efforts to bring a lifesaving drug to patients worldwide.
Additional information will be provided to shareholders in an 8K filing that will be published once the US Securities and Exchange Commission reopens the filing system after the Columbus Day and Indigenous People’s Day holidays.
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This announcement of NRx Pharmaceuticals, Inc. includes “forward-looking statements” within the meaning of the “safe harbor” provisions of the US Private Securities Litigation Reform Act of 1995, which may include, but are not limited to, statements regarding our financial outlook, product development, business prospects, and market and industry trends and conditions, as well as the company’s strategies, plans, objectives, and goals. These forward-looking statements are based on current beliefs, expectations, estimates, forecasts, and projections of, as well as assumptions made by, and information currently available to, the company’s management.
The company assumes no obligation to revise any forward-looking statement, whether as a result of new information, future events, or otherwise. Accordingly, you should not place reliance on any forward-looking statement, and all forward-looking statements are herein qualified by reference to the cautionary statements set forth above.