“NRx has made remarkable progress with all three of our lead programs in recent months. Additionally, as announced today, we have now attracted our first group of fundamental biotechnology investors who have joined us to partner in building a successful commercial enterprise and contributed sufficient capital to reach expected regulatory inflection points. The investor group has aligned its interests in the future growth of our enterprise by purchasing restricted common stock that is subject to a one-year lockup agreement and is devoid of warrants, repricing mechanisms, or other mechanisms that are likely to cause future dilution. Furthermore, the B Group Capital led consortium of investors is strategic as it relates to our efforts to scale-up and develop our HOPE Therapeutics business with the potential to bring future partnerships and operational infrastructure to more quickly realize the potential of our HOPE clinic strategy. Last week, we received a markedly expanded Fast Track designation from FDA that establishes the unmet medical need associated with using NRX-100 to treat suicidal depression in more than 13 million Americans each year. Over the past quarter and in subsequent events, we filed an application under the Commissioner’s National Priority Voucher Program, filed a patent with the USPTO, filed an ANDA for existing indications, and a Citizen’s Petition to remove Benzethonium Chloride from IV ketamine products. The Fast Track determination just received qualifies NRX-100 for the stated requirements of the CNPV. We have continued to advance NRX-101, initiated filing of an NDA for Accelerated Approval in bipolar depression and akathisia, and advanced our development of the HOPE clinic network,” said Jonathan Javitt, CEO. “This continuing flow of accomplishments reflects our commitment to Bringing Hope to Life by delivering life-saving treatments to soldiers, first responders, veterans, and civilians in urgent need.”
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