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Review of ExoFlo paper used to push Direct Biologics IND inside FDA finds red flags

I wrote recently about how political pressure on FDA Commissioner Stephen Hahn in 2020 may have helped the Texas firm Direct Biologics move their product ExoFlo forward inside the agency. Today I analyze the ExoFlo Phase I clinical trial paper used in that push on Hahn and get the firm the IND for a Phase II trial. In my review as …
ExoFlo from Direct Biologics