To Our Shareholders, We have received many inquiries from shareholders following the recent encouraging news regarding Merck’s Molnupiravir results in early COVID-19. We have also received various questions about the status of our application to the US Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) for ZYESAMI. Needless to say, we are […]
You may have noted a previous update regarding communication with the FDA. Earlier this month, NRx received a request for additional clinical information from the FDA. NRx has responded to the information request issued by the FDA with regard to additional clinical information on study patients. Ongoing conversations between the FDA and sponsor of any application […]
I received a very interesting question the other day regarding the history of aviptadil and any regulatory milestones associated with it as a medicine. Below, I outline a brief history of aviptadil and why we believe it may offer patients suffering respiratory distress the opportunity to regain health and get back home to their families. […]
NRx Pharmaceuticals continues to receive many requests for updates on the status of the US Food and Drug Administration’s (FDA) review of NRx’s application for Emergency Use Authorization (EUA) of ZYESAMI™ (aviptadil), to treat patients suffering from Critical COVID-19 with respiratory failure. On September 3, 2021, NRx received a request for additional clinical information from […]
Every day at NRx we get a variety of questions about our science, business, and other aspects of our work. This CEO Update concerns aviptadil and questions about patents for this peptide. Q: What’s the difference between aviptadil and VIP?A: VIP stands for vasoactive intestinal peptide. It is made in specialized cells like insulin. Aviptadil is […]
We have received questions about the data submitted to the US Food and Drug Administration (FDA) in support of our application for Emergency Use Authorization for ZYESAMI™ to treat patients suffering from Critical COVID-19 with respiratory failure. Since there seems to be some confusion about what the preprint says, I’m going to restate the science. ALL PATIENTS […]
