You are a holder and you are not aware of this .... Hmmm
On November 17, a Type A meeting was held with the FDA to discuss the review of the Biologics License Application for remestemcel-L and a potential pathway for accelerated approval with a post approval requirement to conduct an additional randomized controlled study in patients 12 years and older.
Here's the reference, however I am not going to spoon feed you which announcement it formed part of
Ann: Remestemcel-L FDA Fast Track Designation for COVID-19 ARDS, page-477
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