Thursday, April 15, 2021 12:47:53 PM
Post by Relief 2 hours ago
The EUA application has been ongoing since it was originally filed back in September. No new application needed if you listen to Dr. J. In December, the request was denied as submitted based on the small patient set.
Understandable. Dr. J continued to work with the FDelay on what was an appropriate sample size. The RCT trial was designed with the approval of the FDA. The endpoints were approved by the FDA. We provided the agreed upon sample size and the results met the endpoints across ALL patients and sites at 28 and 60 days.
Incredible. No better therapeutic to help critical C19 patients. The FDelay is well aware of what has been accomplished by Zyesami from EAP and RCT patient results.
Soon the world will know. Please relax, the EUA is already under consideration by the FDelay for this amazing therapeutic. Tick tock, buy more of this stock while you wait.
~ Money Making Money ~
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