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 to the FDA are normal, expected, and important to the review process. FDA’s review of NRx’s Emergency Use Authorization application remains ongoing.
Sep. 11, 2021