FDA APPROVAL

Hoth Therapeutics intends to pursue a 505(B)(2) regulatory pathway.

FDA APPROVAL

The FDA allows some of the safety and efficacy information on active ingredients(s) to come from studies not conducted by Hoth. Because Hoth can rely on the historical data, we should have a much shorter time and cost to get BioLexa FDA approved, as compared to standard 505(B)(1) approval.

REGULATORY PATHWAYS