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With regard to the substantial clinical improvement criterion, the applicant asserted that sabizabulin represents a substantial clinical improvement over existing technologies because sabizabulin has been shown to significantly improve clinical outcomes relative to other COVID-19 treatments because in a randomized, multicenter placebo-controlled phase 3 clinical trial, sabizabulin was associated with: reduction of least one clinically significant adverse event (SAE)

It is not approved for human or veterinary use, not intended for diagnostic or therapeutic purposes, and should not be administered to humans or animals under any circumstances

Bajaj JS, Sheikh MY, Chojkier M, Balart L, Sherker AH, Vemuru R, Sussman NL, Vierling J, Morelli G, Anderson KE, Harris MS, Mullen KD

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