Emergency Use Authorization (EUA)

From yesterday's company PR: "..... The Company is in active discussions with various
government and regulatory authorities...."

The FDA can approve Mesoblast's Remestemcel-L NOW based on the EUA provision to treat ARDS:
https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization

"Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA Commissioner may allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents when there are no adequate, approved, and available alternatives.

CBRN stands for Chemical, Biological, Radiological, Nuclear, and Explosive materials.

Hope SI is going to knock on the FDA door to get this going. No trials needed, they could cite the results from the 7 Chinese patients.
Also, If the FDA has such a provision for emergency situations, I am sure other countries do as well.

@benelong : Thank you for your excellent post in delineating between the work Gilead is doing vs Mesoblast.
@doctorwho2: Interesting you mention the possibility of a synergy between Gilead and Mesoblast. Shawn Tomasello who is on Mesoblast's board "has been Chief Commercial Officer at leading immuno-oncology cell therapy company Kite Pharma, where she played a pivotal role in the company’s acquisition in 2017 by Gilead Sciences for $11.9 billion". So there are real opportunities for connections to be made, should Mesoblast pursue partnering opportunities with a big pharma. After all, yesterday's PR did say Mesoblast is in active discussions with pharma cos as well.