This is the next critical step that we needed, prior to a POSITIVE read out.
The FDA don't hand out FTs willy nilly. They are very, very interested in what we are doing.
• We now get more frequent meetings with FDA (very handy)
• Eligibility for Accelerated Approval and Priority Review !!! (big, big, big)
• We don't have to wait for until every section of the NDA is completed (speed)
Now I'm getting more excited. We are getting close.
Not financial advice of course.
Ann: Remestemcel-L FDA Fast Track Designation for COVID-19 ARDS, page-59
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