Hoth Therapeutics, Inc. announced the Pre-IND meeting requested on 22 December 2020 for HT-001 with the U.S. Food and Drug Administration Division of Dermatology and Dental Products has been granted to receive written responses only from FDA that are targeted for delivery on February 22, 2021. HT-001 is a topical formulation under development for the treatment of rash and skin disorders associated with initial and repeat courses of tyrosine kinase inhibitor/epidermal growth factor receptor inhibitor therapy for patients undergoing treatment for cancer. The Pre-IND meeting topics include the acceptability of the overall proposed drug development program for HT-001 including requirements for nonclinical, clinical pharmacology, clinical, chemistry, and manufacturing controls. The proposed clinical trial designs for the first clinical studies (phase 2) in the HT-001 program are also included in the Pre-IND meeting topics to receive FDA feedback.