I would agree that others here have greatly inflated the importance of this announcement (e.g ‘rockets’). However, in the context of the impending DSMB review at 60% and haziness around timing of the 60% review could be suggestive that the FDA might in the process of reviewing data for an EUA. I see this announcement as the first domino in the bureaucracy of FULL approval - even better than an EUA.
Fact check: Remestemcel-L was submitted under a BLA, not an NDA as it is a biologic.
Ann: Remestemcel-L FDA Fast Track Designation for COVID-19 ARDS, page-109
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