(NON-TRADING) COVID-19 ARDS DISCUSSION, page-19

Yesterday I posted something about Medical Counter Measures and EUAs for COVID-19, for a really basic introduction to those follow the link in this post. Many people don't realise the FDA is treating the Pandemic in the USA on the same footing as a CBRN (Chemical, Biological, Radiological or Nuclear) threat. More specific info about MCMs is here https://www.fda.gov/emergency-preparedness-and-response/about-mcmi/what-are-medical-countermeasures. Just as info for newer holders as a bit of background.

Anyway I thought I'd have another look at the current list of Drug Product EUAs which covers therapeutics, where remestemcel-L would fit in. The list has not expanded much, 1 or maybe 2 more products since I looked a few months ago and there is still only one therapeutic, Remdesivir. You can see from the Authorized Use that remestemcel-L would in effect be competing with it as it is part of the current SOC, along with many other existing drugs and procedures on the Primary Measure, to reduce the number of all-cause mortality within 30 days of randomization.


From https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization