Just finished listening to the NRX Q2 review. Here are some notes. Some we knew and some we didn’t. Hope this helps some of you investors out there.
1. Without controls for location or severity Zyesami patients saw a 2x improvement in survival and recovery.
2. Submitted for peer review.
3. 6 fold difference in survival and recovery in tertiary hospitals mirrored the open label 45 patient study.
4. 140 patients enrolled in NIH trial to date with DSMB reporting no safety concerns.
5. Inhalant trial in Non-ICU patients results by end of 2021.
6. Expects EUA decision in coming weeks and is confident.
7. Cardinal Health will be able to deliver drug anywhere in the US within 24 hours.
8. EUA in Georgia with expansion in neighboring areas expected.
9. Zyesami is special in that it can be used in tandem with other drugs.
10. HFNC patients did better than Vented. Tertiary Vented did better than regional.
11. Everybody on drug had 5 fold lower cytokine regardless of severity or location.
12. Inhalant version and IV version expected to treat different populations based on severity.
13. Some hospitals are requesting to use Zyesami through the vent. Unknown if this will work but if it does it would be a huge breakthrough.
14. Still engaging with the FDA to support the EUA application. Confident that trial results are enough to obtain EUA.
15. No timeline exists for EUA review. Feels FDA is moving “uncharacteristically quickly”
16. National physicians society in Georgia reviewed trial results and recommended treatment to prime minister and minister of health in favor of EUA
17. Other medical societies around the globe have requested data for their own independent review.
18. Zyesami does not use buffers in manufacturing of the drug. NRX believes this will lead to data exclusivity and new IP.
19. TFFP and Mankind working towards stable room temperature powder formulation with long term patent protection.
20. Per the collaboration agreement NRX believes Relief has the right to share profits if it funds the development of Zyesami and is working towards a mutually agreeable business relationship going forward