CEO Update: Ongoing ———Communications with the US Food and Drug Administration ———
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 the FDA, and plans to respond to this information request within a week. Ongoing conversations between the FDA and sponsor of any application to the FDA are normal, expected, and important to the FDA’s review process. ———
NRx has responded to three prior information requests since filing the EUA application on May 31, 2021. FDA’s review of NRx’s EUA application remains ongoing ———
This is the process of FDA therapeutic drug approval. Patience is going to pay us very well. ~ Zaran, Y@h00 RLFTF finance conversations >>>
NO PRESSURE???
Read this from the new sec file from 4. of September. This is huge:
"We filed for EUA for ZYESAMI on May 31, 2021 with the FDA and shortly thereafter with the Ministry of Health of the Nation of Georgia based on the results of these trials. Approval in Georgia is expected to provide market access to surrounding Caucasus region countries with a combined population of more than 100 million people." ~ Nick, Y@h00 RLFTF finance conversations >>>
NRx Pharmaceuticals to Work with Cardinal Health to Ensure Efficient Distribution of Potential Therapies ——— —- Agreement Represents Path to Market for ZYESAMI™, as Time to Treatment is Crucial for Patients
—- Cardinal Health Third Party Logistics Services to Provide Logistical and Distribution Support for ZYESAMI™ (aviptadil) Upon Potential FDA Approval
—- Cardinal Health Specialty Pharmaceutical Distribution to Serve as the Exclusive Distributor to Ensure Access to ZYESAMI™ (aviptadil) Upon Potential FDA Approval
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